Position: As a Regulatory Affairs Specialist, you will play a crucial role in supporting the Medical Device Development team in achieving its mission by navigating and ensuring compliance with global regulatory requirements. In this role, you will collaborate closely with the Director of Regulatory Affairs to secure and maintain international regulatory approvals, contributing directly to my client's success in marketing their state-of-the-art medical devices worldwide. This position offers a unique opportunity to grow within the Medical Device regulatory field and significantly impact positive patient outcomes.

Responsibilities:

• Prepare and submit global regulatory applications, including U.S. Medical submissions (Pre-Submissions, 510ks, IDEs, and applicable supplements and annual reports), Canadian Class 3 Device License submissions, EU MDR Submissions, and other international markets such as Japan, Saudi Arabia, Australia, and Brazil.
• Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
• Assess design and manufacturing changes for compliance with applicable regulations and effect on registrations.
• Maintain regulatory files and tracking databases as needed.
• Support quality system audits by notified bodies, government agencies, and customers.
• Obtain Medical Device Certificates to Foreign Government (CFGs).
• Support post-market surveillance, including preparation of post-market clinical follow-up plans and reports. Participate in reviewing complaints and all other post-market-release feedback.
• Submit medical device reports. Support Unique Device Identifier activities.

Requirements:

• Bachelor's degree or equivalent work experience, preferably in an engineering or life sciences discipline.
• 2-5 years of hands-on experience in a Medical Device organization.
• Direct experience with regulatory submissions and management of Class II electro-mechanical medical devices.
• Regulatory affairs experience in generating applications and experience in collaboration with internal and external partners to answer any subsequent questions.
• Knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSRs, ISO 13485, ISO 14971, IEC 60601, 60825, and 62366.
• Experience with lasers and optical technologies is desired but not necessary.
• Strong working knowledge of Microsoft Word and Excel.

#medicaldevice #regulatoryaffairs #510(k) #classII #electromechanical #newposition #ISO13485 #EU #executiverecruitment #laser

Retained Search

Overview: My client, a leading innovative medical device company, seeks a highly experienced and motivated individual to join its team as the Director of Complaint Vigilance.

Responsibilities:

• Lead and manage the Complaint Vigilance department, ensuring compliance with global regulatory requirements.
• Develop and implement strategies for handling product complaints, including investigation, reporting, and corrective actions.
• Oversee the monitoring and trending of complaint data to identify potential product issues and implement preventive measures.
• Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Product Development, to ensure alignment on vigilance activities.
• Maintain up-to-date knowledge of industry standards and regulatory requirements for medical device vigilance.
• Prepare and present reports to senior management on vigilance activities and key performance metrics.

Qualifications:

• Bachelor's degree in a relevant field (e.g., Life Sciences, Engineering). Advanced degree preferred.
• A minimum of 8-10 years of experience in complaint vigilance and quality assurance within the medical device industry.
• Proven leadership experience with a track record of managing teams and complex projects.
• In-depth knowledge of global regulatory requirements for medical device complaint vigilance, including FDA and EU MDR regulations.
• Strong analytical skills and the ability to interpret complex data.
• Excellent communication and interpersonal skills.

#medicaldevice #complainthandling #complaintvigilance #complainthandling #qualityassurance #mdr #postmarketsurveillance #newpositon #retained #executivesearch

Position: The Principal Quality System Specialist will be responsible for reviewing, improving, and maintaining the quality system, including the Quality Manual, procedures/processes, training, and complaint handling. This includes quality planning, training, vendor approval/monitoring, equipment calibration, complaint handling and trending, product recalls / advisory notices, corrective and preventive action systems, and internal and supplier quality audits.

Onsite Position - Located in the Greater Boston area.

Responsibilities:

• Drive continuous improvement.
• Continuously monitor and make recommendations to improve processes and procedures.
• Lead problem-solving teams through root cause investigations and failure analysis to implementation and final verification.
• Create relationships across the business that enable the sharing of knowledge, best practices, and solutions.
• Assist with implementing Quality Management-approved solutions to ensure compliance through effective, efficient, and sustainable QMS processes.
• Support, as needed, regulatory assurance, vigilance/incident reports & post-market surveillance.
• Support risk analysis activities associated with the QMS processes and drive a risk-based approach.
• Conduct Internal Audits of the Quality System and Supplier.
• Monitor supplier performance scorecard and management of supplier improvement activities.
• Prepare for and participate in audits by external organizations, such as FDA, ISO, etc.
• Lead and develop direct reports.

Requirements:

• Bachelor’s degree in science or engineering.
• 10-15 years of experience in Medical Device Quality Assurance.
• 5 years of hands-on management experience.
• Experience using tools such as CAPA, Six Sigma methodology, change control, Statistical Analysis, and Control Plans.
• Experience in stakeholder management and team leadership.
• Solid understanding of applicable regulations, including FDA 21 CFR Part 820, ISO 13485.
• Proven ability to support multiple projects and be results-oriented.
• Highly motivated and hands-on, consistently able to follow through on projects.
• Superior English language communication skills, written and verbal.
• Ability to interact effectively with all levels of personnel within the organization and external customers.
• Excellent organizational skills and attention to detail.
• Demonstrated ability to navigate through ambiguity and rapid growth and adapt to change.
• Understanding of Health Canada MDD’s, European MDR’s, MDSAP preferred.
• Quality Auditor Certification preferred.
• Six Sigma Experience / Certification.
• Knowledge of Medical Device start-ups is a plus.

#medicaldevice #qualityassurance #qms #qualitysystemsmanmanagement #complaintmanagment #leadership #newposition #executivesearch #audit #compliance

Reports To: Chief Medical Officer (CMO)

Position Overview: We are seeking a visionary leader passionate about advancing the field of psychedelic medicine. In this dynamic role, you will work closely with the Chief Medical Officer (CMO) to provide clinical expertise across various stages of the drug development process. The ideal candidate will have a passion for clinical research involving novel therapeutics (e.g., psychedelic drugs) and a proven track record of relevant clinical development within the pharmaceutical industry.

Responsibilities:

• Provide comprehensive medical oversight for sponsored clinical trials.
• Ensure the overall safety of clinical trial participants, serve as physician contact for CRO medical monitor(s), support safety reporting and pharmacovigilance activities, and manage medical emergencies if they occur.
• Collaborate with Clinical Operations and designated CROs to execute the clinical trials (e.g., perform data and coding reviews; draft/present clinical slides for Investigator Meetings; participate in DSMB planning therapeutic/monitor training; develop/review key study plans).
• Collaborate with the Regulatory Affairs team regarding clinical development strategy and preparation of regulatory submissions (e.g., investigator brochures, annual reports, clinical study reports, meeting briefing documents, etc.).
• Collaborate in designing and optimizing study protocols to ensure they are scientifically rigorous and ethical, and appropriately address key clinical questions to support future marketing application(s).
• Oversee the collection, analysis, and interpretation of clinical data. Ensure the accurate and timely reporting of trial results and conclusions (i.e., in clinical study reports, abstracts, and manuscripts).
• Engage with key stakeholders regarding drug development activities and strategy. Provide clinical support in interactions with internal and external partners (e.g., regulatory authorities, key opinion leaders, data safety monitoring boards, advisory boards, patient advocacy groups, etc.).
• Provide leadership and mentorship to the clinical trial team(s) and other staff, as appropriate. Contribute to medical/scientific training regarding the therapeutic area and drug(s) under development. Foster a collaborative multidisciplinary team environment by communicating relevant research findings and clinical insights. Support SOP development and process improvement activities.
• Understands and complies with ethical, legal, and regulatory requirements applicable to our business.

Qualifications:

• Medical Degree (MD or DO) with board certification in Psychiatry, Neurology, or a related field.
• Extensive experience designing and conducting clinical trials, particularly late stage (Phase 2/3), with a deep understanding of clinical trial methodology and relevant FDA regulations and guidance.
• Is proficient with medical coding activities (i.e., MedDRA, WHO Drug).
• 5 years of relevant experience in the pharmaceutical industry.
• Clinical expertise in psychiatric disorders of potential clinical development interest (e.g., major depressive disorder, post-traumatic stress disorder, acute stress disorder, prolonged grief disorder, adjustment disorder, etc.).
• Publication record in relevant therapeutic areas or clinical trial-related topics.
• Prior experience in managing large, multicenter clinical trials.
• Deep understanding of psychedelic-assisted therapy and the psychopharmacology of psychedelic drugs.
• Proven experience contributing to regulatory submissions and interactions with the FDA, including knowledge of relevant regulations and guidance, IND applications, advisory committee-related activities, and Risk Evaluation and Mitigation Strategies (REMS).
• Demonstrated leadership skills with the ability to manage a multidisciplinary team effectively.
• Strong verbal communication and technical writing skills.

#clinicaltrials #executivesearch #lifesciences #hiring #medicaldirector #pharmaceutical #psilocybin #psychedelic #psychiartry #psychiatricdisorders

Our client is a commercial-stage medical device company dedicated to improving patient outcomes through innovative products. With a focus on excellence and quality, they are at the forefront of the medical device industry, delivering cutting-edge solutions to healthcare providers globally.

Position Overview: We are seeking a highly skilled and experienced Senior Director of Operations to join our client's dynamic team. In this key leadership role, you will oversee and optimize the manufacturing programs, ensuring the highest operational efficiency and compliance with regulatory requirements. You will lead a team of Operations Managers, fostering a culture of collaboration and continuous improvement to drive the success of our manufacturing operations.

Onsite Position - Greater Boston Area

Responsibilities:

• Achieves local, onsite operational goals, including productivity, quality, cost, delivery, safety, and colleague engagement requirements while strictly adhering to FDA and other government and local regulations.
• Responsible for oversight of the Operations Managers and their teams.
• Oversees the external manufacturing, servicing, maintenance, and distribution of class II medical device products, ensuring consistently meeting safety, production, performance, and quality standards.
• Review operations, servicing, maintenance, and distribution reports to ensure safety, quality, financial, and delivery goals and standards are met.
• Develop and implement a risk-based oversight program for all outsourced manufacturing, servicing, and maintenance operations to ensure full compliance with FDA regulations.
• Ensures the proper operational controls, metrics, procedures, and personnel are in place to grow the organization for financial and operational efficiencies effectively.
• Stay abreast of industry trends and best practices in operations management.
• Assists VPs of Engineering, Sales, and Finance with long-range operating goals, expansion efforts, and new and advanced technology/product implementation.
• Develop and execute strategies to maximize production efficiency, reduce waste, and improve overall operational performance.
• Monitor key performance indicators (KPIs) such as CFR, on-time shipment, cycle times etc.; implement corrective actions as necessary to achieve operations goals.
• Lead and support lean manufacturing initiatives, process improvement projects, and the implementation of new technologies to enhance productivity.
• Foster a culture of innovation and creativity in problem-solving.
• Works with the Finance Team to develop an operating budget and ensure cost controls in the manufacturing process.
• Delivers progress and production reports to executive team members as requested.
• Supervises equipment purchase, maintenance, and layout.

Requirements:

• Experience in the medical device industry is required.
• Bachelor’s degree in Manufacturing, Engineering, Business, or a related field (Master's degree preferred).
• Proven experience in manufacturing leadership roles, with at least 10 years of experience in a similar position
• Proven track record of success in leading and optimizing operations at a senior level.
• In-depth knowledge of key supply chain/logistics processes and best practices.
• Knowledge of Quality Control, Manufacturing Engineering, Purchasing, Planning, Inventory Control, Document Control, Shipping and Receiving, Facilities and maintenance, FDA GMP, and ISO 13485 regulations.
• Strong understanding of manufacturing processes, quality management, and continuous improvement methodologies (e.g., Lean, Six Sigma).
• Excellent leadership, team building, and communication skills.

#medicaldevice #medicaldevicemanufacturing #operations #seniordiredctor #supplychain #quality #leadership #fda #newposition #executivesearch #newproductdevelopment

Our client is a commercial-stage medical device company dedicated to improving patient outcomes through innovative products. With a focus on excellence and quality, they are at the forefront of the medical device industry, delivering cutting-edge solutions to healthcare providers globally.

Position: The Manager of Quality Systems and Compliance will be responsible and accountable for compliance with US FDA regulatory requirements and company procedures and policies.  This position is a key interface between all functions within the company that execute activities pertaining to 21 CFR Parts 820 and 803.

Responsibilities:

• Ensure full compliance with 21 CFR 820, 21 CFR 807, 21 CFR 803, ISO 14791, FDA Guidelines
• CAPA, Risk Management, and other relevant FDA, ISO, ICH, and Industry Standards and Guidelines.
• Developing, implementing, and maintaining the Quality Manual and Quality Management System (QMS).
• Ensuring all QMS Element SOPs comply with applicable regulations.
• Manage the Document Control QMS Element, including an electronic Document Management system and compliance with FDA requirements and the Record Retention Policy.
• Managing the CAPA program.
• Manage the Quality Engineering function, ensuring proper tools and processes for administration of the QMS. 
• Managing the Internal Audit Program to prevent unfavorable FDA Inspection outcomes.
• Managing a team with responsibility for the execution of the QMS.
• Managing key aspects of the Front Room during FDA Inspections and third-party audits, such as the documents requested/reviewed log and daily transcripts.  
• Leading the Back Room during FDA Inspections and third-party audits.
• Leading the Escalation to Management Process; developing slide decks/overviews, and meeting minutes for Escalation to Management and Quality Review Board Meetings.
• Creating and presenting metrics for quarterly Quality Management Review Meetings; maintaining Quality Management Review slide decks and preparing Quality Management Review Meeting minutes.
• Managing the GMP Training QMS Element and associated IT Tool(s) used for training curriculum and training records.
• Leading Field Action Tactical Team(s).
• Conducting GMP training for all employees annually.
• Maintaining a strong collaborative partnership with cross-functional team members to facilitate a favorable compliance profile, protect patient/user safety, comply with all applicable Regulations, and meet business needs.
• Maintaining positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Requirements:

• Quality Management System Protégé or Mastery level knowledge and expertise
• Product Knowledge Student or Protégé level knowledge and expertise
• First-hand knowledge of Infusion Pump Technology and Software as a Medical Device.
• General Quality Assurance and Quality Systems Protégé or Mastery level knowledge and expertise.

Qualifications:

• BS degree in Engineering and/or science discipline; MS degree in Engineering and/or science discipline preferred.
• Seasoned Quality professional/leader with 5-8 years of experience, including people management, in the medical device industry, preferably in developing and maintaining Quality Management Systems for Class II or III medical devices.
• Demonstrated applied knowledge of regulatory requirements for Medical Devices (ISO 14971 and 21 CFR 820 at a minimum).
• Demonstrated leadership experience through formal and informal assignments.
• Results-orientated, multi-tasker, and quick learner; understands and responds to urgency.
• Able to successfully manage workload to timelines.
• Excellent verbal, written, and interpersonal skills.
• Applied knowledge of Microsoft Office software including Excel, Word, and PowerPoint

#qms #qualitymanagementsystems #compliance #medicaldevice #qualityassurance #infusionpumps #Protégé #newjobalert #capa

Retained Search - Hybrid Position Boston (or) Pennsylvania

Role: Director of Global Regulatory Affairs CMC, will provide regulatory leadership for CMC matters related to T-cell therapies for the treatment of cancer. You will work cross-functionally with various teams, including R&D, clinical development, manufacturing, and quality assurance, to develop and execute regulatory strategies that support these therapies' development, registration, and life-cycle management.

Organization: My client is a growing immune-oncology company and leader in T-cell therapies focused on transforming the lives of cancer patients. They are breaking new ground with science and technology, making now a perfect time to join their incredibly collaborative and patient-focused team.

Key Responsibilities:

• Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
• Acts as point of contact to cross-functional teams on regulatory CMC project issues. Ensures project teams, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating professionally and on time.
• Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners, and CROs) to develop and execute robust CMC regulatory strategies.
• Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
• Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
• Ability to remain current on CMC regulatory intelligence, including guidelines and regulatory trends, and to drive and implement strategic policy decisions.
• Evaluate change proposals for global regulatory impact and plan global amendments.

Qualifications & Experience:

• Experience in cell and gene therapy required.
• Experience with BLAs/NDAs/MAAs required.
• Bachelor's Degree required; advanced Degree preferred.
• Minimum of 10 years of pharmaceutical/biotech experience, including 5 years of Global Regulatory Affairs CMC experience.
• Experience as a RA CMC product lead.
• Experience with pharmaceutical development of drug substance or drug products, analytical characterization, process scale-ups, and or regulatory registration of products.
• Understanding and proven ability to provide strategic guidance to drug development, registration, and post- market support teams.
• Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/ specific regulatory guidance.
• Proven experience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs).
• Proven ability to liaise with Regulatory Agencies, having led successful Agency interactions related to CMC submissions and product development meetings; international experience preferred.
• Knowledge of relevant domestic and global regulations and guidance.

#cmc #regulatorycmc #regulatoryaffairs #celltherapy #cancerimmunotherapy #oncology #car-t #newposition #hybrid #director

Retained Search

Our client is seeking an experienced and strategic leader to join their team as the Vice President of Quality Assurance & Compliance. In this critical role, you will be instrumental in ensuring the highest standards of quality and regulatory compliance across the organization. Reporting directly to the executive leadership team, you will lead the Quality and Regulatory Assurance and Compliance efforts, driving the implementation and adherence to the Quality Management System (QMS) and driving product quality performance to meet or exceed industry standards.

Responsibilities:

• Lead a team of the following disciplines: Product QA, Software QA, Quality Systems, and Post Market Surveillance.
• Responsible for maintaining compliance and the continuous improvement in the Quality & Regulatory Management System regarding ISO 9001, ISO 13485, ISO 14001, IEC 62304, EMS, CMDR SOR/98-282, MDD 93/42EEC and MDR 2017/745, and 21 CFR Part 820 and further regulatory requirements which apply to the product portfolio.
• Serve as the point of contact with the Notified Bodies.
• Serve as the primary contact for FDA, TÜV, regulatory, and third-party audits and inspections and/or preparation as necessary.
• Ensures that the cross-functional organization is aligned and prepared for audits and inspections.
• Defines Quality & Regulatory Management goals and ensures alignment with other relevant business goals.
• Analyzes and reviews quality management goals and breaks down corresponding goals for the relevant product quality targets.
• Drives the achievement of the agreed-upon targets to achieve business targets in both Quality and Process Performance.
• Refines and fosters a set of necessary quality statistics and methodologies. Responsible for CAPA, PQB, and QMS Boards.
• Serves as the Management Representative for ISO 9001, ISO 13485, FDA, ISO 14001 and as Person Responsible for Regulatory Compliance.
• Also responsible for providing periodic reporting on a local and global level.
• Provide leadership and guidance to and oversight of internal and external resources to ensure the company remains in compliance with applicable and phase-appropriate quality-related standards, regulations, and cGMP practices.
• Establish and maintain the quality & regulatory systems, including cGMP compliance, document control, training, CAPA, quality metrics, internal audits, management controls, software quality, and post-market surveillance.
• Serves as a member of the Management Team, provides information to management that could impact QA compliance, and promotes awareness of customer requirements and feedback to the management team.
• Manage Department budget and resources to address strategic needs within the Quality & Regulatory department, including hiring decisions, talent management, and mentoring development.
• Responsible for the implementation of an Integrated Management System.
• Ensure effective Quality System implementation within the CFTs and Product Steering Boards. Educates responsible organizations in all commercial and quality/process-relevant topics.
• Drives Software Quality Assurance (SWQA) and Compliance for new developments and legacy products. Promotes awareness of customer requirements, monitors quality performance, and communicates customer quality issues and resolution thereof.
• Assures product quality by involvement in the development process.

Requirements:

• Bachelor’s Degree in a scientific discipline, life sciences, biomedical or other engineering science - Master’s or a PhD (desired).
• Quality and Environmental (knowledge of current ISO 9001, ISO 13485, IEC 62304, ISO 14001).
• CMDR SOR/98-282, MDD 93/42/EEC and MDR 2017/745, 21 CFR Part 820, where applicable.
• A formal Six Sigma qualification is preferred.
• Minimum of 15 year’s experience in either a quality or regulatory role in the medical or safety device industry with at least 7 years in a management role.
• Ability to develop, implement, and manage an integrated QMS; to lead multi-level and multi-discipline work teams to develop, implement, and manage processes/business systems.
• Prefered experience in managing both quality and regulatory.
• Strong influencing skills at all levels to lead the decision-making process with executive management, peers, and subordinates.
• Sound people management and change management experience.
• Strong interpersonal and communication skills and the ability to persuade and influence others at all levels within the company.
• Capacity for analytical thought
• Proven track record in applicable disciplines of ISO 9001, ISO 13485, IEC 62304, US FDA and MDD compliant Quality Management and ISO 14001 Environmental Management systems and demonstrated success in developing a proactive organization in a compliant environment.

#medicaldevice #qualityassurance #compliance #qualitymanagment #regulatorycompliance #qualitysystems #qms #leadership #executivesearch #regulatoryaffairsrecruiter

Shepherd Regulatory Search has been engaged for a newly created Remote Senior Director Regulatory Affairs position.  This role will provide regulatory expertise from preclinical through clinical development for assigned programs.

Organization: Our client is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative treatments for severe, rare muscle disorders for which there is a significant unmet medical need. 

Location: Remote

Responsibilities:

• Oversees the writing, editing, reviewing, and compiling of documents needed for regulatory submission activities for US and global assigned products.
• Provides critical review of all documentation supporting regulatory submissions and communications.
• Prepares and submits regulatory applications, annual reports/IND amendments, and meeting requests to FDA and other regulatory agencies.
• Reviews and prepares responses to requests from regulatory authorities.
• Provides leadership for regulatory document management systems and maintains corporate regulatory files.
• Ensures regulatory milestones are met to support regulatory submission and overall business goals of the Company.
• Contribute to the development of regulatory strategies.
• Research and identify new opportunities outside of assigned work that augments the Company’s mission, vision, values, and goals.
• Effectively manages and mentors regulatory staff.
• Oversees assigned external vendors and contractors responsible for providing regulatory support functions to ensure goals are achieved.
• Primary liaison with regulatory agencies and interacts with senior management to report on project or program milestones.
• Provides strategic or operational input to project team.
• Builds professional and effective external relationships crucial to the success of the organization.
• Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders.
• Fully involved and responsible for all areas of communication with FDA and other government regulatory authorities.

Experience:

• Experience in Cardiology is strongly desired.
• BS/BA degree in a scientific/health sciences discipline.
• 10+ years experience in pharmaceutical Regulatory Affairs.
• Experience preparing submissions, regulatory documents, annual reports, amendments, and supplements.
• Proven ability to strategize with team members on the optimal way of documenting various submissions and determining the preferred plan.
• Management expertise on the timeline and process for submissions.
• Expert knowledge of regulations and guidance’s affecting routine regulatory activities and specific therapeutic areas and keeps abreast of the regulatory environment.
• In-depth knowledge of overall global drug development.
• Excellent written, interpersonal and communication skills.
• Action-oriented and committed to meeting FDA and other regulations while moving projects forward.
• Able to handle changing priorities and multidisciplinary tasks.

#remote #remotejobs #regulatoryaffairs #cardiology #directorregulatoryaffairs #seniordirectorregulatoryaffairs #newposition #lifesciences #regulatorystrategy #drugdevelopment #clinicaltrials #FDA #regulatoryaffairsrecruiter

Retained Search - Hybrid Position

Position Overview: Responsible for overseeing and managing the quality function and all aspects of quality. Establish and maintain a robust quality management system, processes, and procedures to ensure compliance with applicable health authority regulations, guidelines, and standards. Represent quality on the management board/leadership team. Serve as the primary point of contact for quality-related matters during regulatory inspections, audits, and customer inquiries.

Responsibilities:

• Develop and implement a comprehensive quality strategy and roadmap aligned with business objectives and regulatory standards.
• Develop and implement the Quality Goals and Objectives.
• Develop the quality budget.
• Collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, to ensure seamless integration of quality standards throughout the product life cycle.
• Oversee the supplier quality and third-party oversight program, including audits to identify potential quality issues, deviations, or non-conformities, and implement appropriate corrective and preventive actions.
• Stay abreast of evolving regulatory requirements and industry trends to proactively identify process improvement and innovation opportunities.
• Foster a quality and continuous improvement culture by organizing training programs, workshops, and knowledge-sharing initiatives.
• Lead management review. Serve as the management representative. Chair the Quality Board; holds the responsibility for market actions.
• Responsible for Post Market and Complaint Vigilance.
• Responsible for the Quality Aspect of Design Control.
• Lead continuous improvement initiatives, implement digital quality strategies, and drive simplification of processes.
• Driving quality culture.
• Responsible for company-wide training.
• Ensure quality strategy is aligned with business needs and integrated into company goals and objectives.
• Monitor quality skills and capabilities as the business evolves.

Requirements:

• Bachelor’s degree in science or engineering with 15+ years of experience in medical devices or Master’s degree with 12+ years of experience in medical devices.
• Deep working knowledge of quality systems and compliance.
• Demonstrated success in leading and managing a team of quality assurance professionals, providing guidance, coaching, and performance evaluations.
• Experience hosting and facilitating regulatory inspections and skilled in interacting with government officials.
• Strong technical judgment and advanced leadership skills.
• Strong risk management skills.

#medicaldevice #qualityassurance #leadership #training #newposition #strategy #riskmangment #qualityauditing #medicaldevicequality #executivesearch

Retained Search - Hybrid Position

Position Overview: The Vice President of Regulatory Affairs will be responsible for developing and leading the Regulatory strategy while providing strategic and operational leadership to the organization. In this role, you will lead and manage a team of regulatory affairs professionals, providing guidance, coaching, and performance evaluations.

Responsibilities:

• Development of Regulatory Strategies that optimize product development and registration.  
• Lifecycle management of new and marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.
• Lead and manage a team of regulatory affairs professionals, providing guidance, coaching, and performance evaluations.
• Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to the management teams.
• Advises project teams regarding the development and implementation of regulatory strategy. Maintains awareness of the changing regulatory landscape and advises the team on changes that could impact future development.
• Accountable for ensuring regulatory compliance of all external materials.
• Maintain current knowledge of the global requirements and changes to applicable laws, regulations, and industry standards, and assist in disseminating this information to the appropriate individuals within the company.
• Interpret new and existing regulatory requirements related to the products and initiate actions to assure compliance with these regulations.
• Support where required internal and external audits/inspections.
• Manage the regulatory budget.
• Works with the management team to ensure all company regulatory programs achieve internal expectations.
• Ensure regulatory strategy is aligned with business needs and integrated into company goals and objectives.
• Monitor regulatory skills and capabilities as the business evolves.

Requirements:

• A minimum of 15 years of experience in a Regulatory leadership role within Class II medical devices.
• Bachelor’s degree in science or engineering.
• Experience with electro-mechanical medical devices.
• Experience with FDA remediation.
• Demonstrated track record in securing product approvals.
• Have excellent communication and presentation skills with the ability to influence and demonstrate a track record of accomplishment in presenting, interacting, and building effective relationships internally and externally.
• Expert knowledge of the FDA regulations and base knowledge of global markets.
• A detailed knowledge of Quality Management Systems and their requirements for regulatory purposes - 21 CFR 807, QSR, ISO 13485 Medical devices.
• An understanding of ISO 14971 Medical devices and the application of risk management to medical devices.

#medicaldevice #regulatoryaffairs #regualtorystrategy #medicaldeviceregulatoryaffairs #executivesearch #retained #hybrid #electromechanical #newposition #regulatoryaffairsrecruiter

Retained Search

Position Summary: The Director RA/QA is responsible for building, advancing, and sustaining the Quality Management System (QMS) and ensuring that it meets applicable state, federal, and international regulations and business quality standards. Additionally, this role is responsible for establishing a regulatory strategy and maintaining compliance with applicable regulatory requirements. The Director RA/QA will be supported by consulting Subject Matter Experts (SME) for both Regulatory Affairs and Quality Assurance.

Responsibilities:

• Lead maintenance and advancement of the company QMS including sustaining its certification to ISO 13485.
• Establish and maintain compliance with Class I/II medical device regulatory requirements for the US and Canada through Regulatory strategy and ongoing reviews of product and regulatory guidance changes.
• Establish and maintain compliance with Data Privacy and Security regulatory requirements.
• Serve as the Organization’s Management Representative (MR), the point of contact for all quality and regulatory communication with applicable agencies and bodies.
• Process owner for all QMS processes.
• Responsible for working with Engineering and Operations to advance the Design Control systems and develop validation/qualification protocols and Risk Management files that meet applicable Regulations, Guidance, and Procedures.
• Conduct internal audits and coordinate and manage external ISO/Regulatory audit schedules, correspondence, and closing of findings.
• Effective and timely review of change orders and technical documentation.
• Review, audit, and approve Device Master Records, Design History Files, and ensure that the records and files are updated.
• Responsible for managing RA/QA department, including internal and external resources and partners.
• Responsible for reviewing and establishing the company quality goals and objectives each year and leading Management Reviews.
• Establish and maintain Key Process Indicators.

Requirements:

• BS in Engineering, Regulatory Affairs, Quality Engineering, or equivalent technical degree.
• 5+ years of medical device management experience.
• Demonstrated aptitude in leading teams and organizations that comply with 21 CFR 200 et al, 21 CFR 820, 21 CFR 830, SOR/98-282, and ISO13485.
• Regulatory compliance related to medical device industry, including experience submitting medical device applications for US and Canada.
• Knowledge of Data Privacy and Security Regulations and Standards.
• Proven experience working directly with domestic and foreign regulatory authorities.
• Ability to analyze and interpret standards and government guidance and regulation documents and translate into internal strategies and policies.
• Ability to write standard operating procedures, work instructions, specifications, and technical reports.
• Ability to effectively communicate company status, goals, and initiatives throughout the organization.
• Demonstrated success in leading teams and departments, including external partners.
• Ability to effectively communicate company status, goals, and initiatives throughout the organization.
• A hands-on leader willing to work side by side with a small, agile team.
• Certified Quality Auditor (CQA) - Regulatory Affairs Certification (RAC) - Six Sigma Certification -Experience with Veeva Software preferred.
• Experience with all applications in Microsoft Office 365.

#medicaldevice #qualityassurance #regulatorystrategy #certifiedqualityauditor #qualitymanagmentsystems #iso13485 #designcontrol #managment #qms #audit

Position Overview: The Complaint Vigilance Director will lead the strategic direction and ensure the success of the Complaint Handling, MDR, and post-market reporting programs. In this role, you will be responsible for managing the Vigilance Team. Responsible for team goal setting, performance assessments, and day-to-day people management. Ensures complaints management procedures are optimized and that the vigilance team responds to and resolves complaints within a timely fashion while conforming to the correct standards and procedures. 

Responsibilities:

• The primary interface to other department heads and upper management for complaint-related topics and trends.
• Execute complaint vigilance in conformance to current standards and procedures, using applicable system application tools in accordance with 21CFR820 / 21CFR803 and other regulations as required. 
• Oversee the triage assessment of complaints and assess initial risk and severity; Oversee the receipt, evaluation, investigation, and closure of complaints, including device malfunctions.
• Makes critical decisions for the Complaint Handling Unit (CHU).
• Work with all product/manufacturing/research & development/quality teams to ensure timely, accurate, and complete investigations of product complaints and timely closures.
• Review reports of complaint trends.
• Oversee the assessment of complaints for MDR reportability to the FDA.
• Ensure initial and follow-up reports are submitted to Regulatory Agencies within the required timelines.
• Ensure complaints are classified correctly and that all supporting data are adequately documented and attached to the complaint file.
• Ensure procedures meet current and evolving requirements.
• Review metrics on process timeliness and effectiveness.
• Oversee post-market surveillance activities.
• Review and approve Complaint Vigilance Reports (i.e. quarterly trending, monthly complaint records) in a timely manner.
• Conduct annual complaint training for all employees, including field sales, on the requirements to report complaints in a timely manner.

Requirements:

• Bachelor’s degree in science or engineering with 10+ years of experience or Master’s Degree with 7+ years’ experience in medical devices.
• Medical Device experience required.
• Extensive experience and deep working knowledge of complaint vigilance and MDR reporting. 
• Experienced in regulatory inspections and skilled in interacting with government officials.
• Experience with 21CFR820 / 21CFR803 and other regulations as required.
• Experience with post-market surveillance activities.

#medicaldevice #complaintmanagment #complaintinvestigations #mdr #reporting #newpoisition #hybrid #boston #executivesearch #director

My client seeks a highly skilled and experienced Principal Regulatory Affairs and Quality Medical Device Professional. In this role, as a pivotal member of the team, you would lead Regulatory Strategy and Compliance for a diverse range of medical devices. Working closely with cross-functional teams to ensure products meet global regulatory standards, providing safe and effective solutions for healthcare providers and patients. If you are passionate about ensuring the safety and effectiveness of medical devices, this is the perfect opportunity to impact healthcare worldwide positively.

Position: The initial focus of this role will be to ensure that regulatory files are compliant for 510K, de Novo, and PMA submissions; identify gaps between 21 CFR Parts 800-1299 and EU MDR requirements, and ensure regulatory files are compliant with US regulatory requirements.

Responsibilities:

• Develop and execute US Regulatory Strategies for product development and submissions, ensuring alignment with global regulations and standards.
• Maintain compliance with relevant regulations, standards, and guidelines throughout the product lifecycle.
• Assist in preparing responses to US regulatory authorities' questions within assigned timelines.
• Recommends changes for clinical protocol for US regulatory compliance.
• Recommends strategies for earliest possible approvals of clinical trials applications in US.
• Assist in preparing clinical trial site ethics review board/FDA applications for investigational device trial(s). Review interim or final reports for trial site ethics boards/FDA as required.
• Conduct risk assessments and collaborate with product development teams to mitigate potential regulatory risks.
• Ensure product labeling and packaging comply with US regulatory requirements.
• Act as a liaison between the Company and FDA, respond to inquiries and requests for information.
• Performs coordination and preparation of document packages for audits and inspections from all areas of the company, providing regulatory input to minimize the potential for findings of non-compliance.
• Provide guidance and training to cross-functional teams on regulatory requirements and updates to raise US requirements knowledge within the Company.
• Stay abreast of regulatory procedures and changes in regulations, standards, and industry trends to anticipate and adapt to evolving requirements.

Qualifications:

• Experience with 510(k) submissions and PMA applications required.
• Minimum of ten years of regulatory affairs experience in the medical device industry required.
• Bachelor's degree in a relevant scientific or engineering field required (advanced degree preferred).
• Strong knowledge of FDA regulations (21 CFR 812, 814 and 820), ISO standards (ISO 13485: 2016, ISO 14971: 2019).
• Excellent knowledge of the applicable medical device regulations in various countries--including current developments (EU-MDR) is an advantage.
• Ability to work collaboratively in a cross-functional team environment.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational abilities.
• Independent, reliable, and communicative personality for delivering high-quality.

#regulatoryaffairs #medicaldevice #510(k) #PMA #director #quality #regulatoryaffairsmedicaldevice #newjobalert #globalregulatoryaffairs #executivesearch

Hybrid Position: Philadelphia (or) Boston

My client is a late-stage global biotechnology company developing first-in-class T-cell-based cancer immunotherapies. They are seeking an Associate Director of Regulatory Affairs to lead, develop, and execute global regulatory strategies for assigned programs.

Position: Reporting directly to the Vice President of Regulatory Affairs, you will serve as the primary liaison to regulatory agencies and lead submission activities. The Associate Director of Regulatory Affairs will be responsible for developing, implementing, and leading global regulatory strategies designed to facilitate the success of our products across their entire lifecycle.

Responsibilities:

• Leads and defines the global regulatory strategy and executes regulatory strategies.
• Preparation and supervision of preparation of regulatory submissions, including INDs, CTAs, GMOs, IDEs, amendments, annual reports, meeting briefing documents, responses to regulatory agency information requests, marketing authorization applications, and other regulatory submissions, as applicable.
• Serves as the primary liaison with FDA and other regulatory agencies throughout the development of projects, including support for regulatory agency meetings and teleconferences.
• Identify and assess existing and new regulations, guidance documents, international standards, or consensus standards; provide interpretive guidance and ensure applicable implementation into development planning and execution.
• Ensures that all regulatory activities and documents submitted to regulatory agencies are evaluated to ensure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance to facilitate agency review and acceptance.
• Represents Global Regulatory Affairs as the primary contact on regulatory aspects of the projects and as a member of the cross-functional project team, providing regulatory guidance/strategy/perspective in team meetings and presentations at senior leadership governance meetings.
• Participate in due diligence activities on potential licensing, acquisition, or collaboration opportunities.
• Reviews and establishes standard operating procedures (SOPs) and global regulatory affairs processes.
• Manages vendors and clinical research organizations (CROs) performing regulatory activities on behalf of the company.
• Ensure regulatory documentation is maintained appropriately.

Qualifications & Experience:

• Bachelor’s Degree required. Advanced Degree preferred.
• At least 6 years of Global Regulatory Affairs experience.
• Must have Cell or Gene Therapy experience.
• Must have experience filing regulatory dossiers (CTAs, INDs, IMPDs, IDEs)
• Oncology experience is strongly preferred.
• Experience with BLAs/NDAs/MAAs preferred.
• Solid working knowledge of relevant domestic and global regulations and guidance.

#lifesciences #newjobalert #regulatoryaffairs #celltherapy #oncology #biotech #executivesearch #regulatorystrategy #drugdevelopment #regulatoryaffairsrecruiter