Join our client's dynamic team as a Senior Regulatory Affairs Specialist. In this role, you will be pivotal in supporting their Medical Device Development team. Your expertise will be crucial in navigating and ensuring compliance with global regulatory requirements. This role offers an exciting opportunity to work closely with the Director of Regulatory Affairs to secure and maintain international regulatory approvals, directly contributing to our client's success in marketing their state-of-the-art medical devices worldwide.

Onsite Position - Located in MA

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.
• A minimum of 4 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 #SeniorRegulatoryAffairsSpecialist #RegulatoryAffairs #ElectroMechanical #NewPosition #510k #MDRSubmissions #MedicalDeviceDevelopment #RegulatorySubmissions #ExecutiveRecruiter

Position: Director of Clinical Operations

Reports To: Chief Medical Officer

Position Overview: The Director of Clinical Operations will oversee the planning, execution, and management of psychedelic clinical trials. Reporting directly to the Chief Medical Officer, this role requires a highly experienced professional with a proven track record in clinical operations, strategic oversight, and regulatory compliance. The successful candidate will be key in shaping and advancing the company's drug development programs while ensuring operational excellence and clinical success.

Responsibilities

Strategic Leadership:

• Develop and implement clinical operations strategies aligned with company goals.
• Provide leadership and direction to the Clinical Operations team.
• Collaborate with cross-functional teams to ensure the successful execution of clinical trials.

Operational Management:

• Oversee the planning, initiation, and execution of clinical trials.
• Ensure trials are conducted in compliance with all FDA regulatory requirements, Good Clinical Practice (GCP) guidelines, and organizational SOPs.
• Manage clinical trial budgets, timelines, and resources to ensure efficiency and cost-effectiveness.
• Proactively identify risks and lead team members to mitigate risks in a timely fashion.
• Understands and complies with ethical, legal, and regulatory requirements applicable to our business.

Team Development:

• Mentor and develop Clinical Operations staff, fostering a collaborative and high-performance culture.
• Conducted performance evaluations and supported career development for team members.

Embrace and Utilize AI Tools:

• Demonstrate a genuine curiosity and enthusiasm for leveraging AI technologies to enhance efficiency, improve processes, and drive innovation within your role. Willingness to learn and adapt to new AI tools is essential.

Vendor Management:

• Select and manage relationships with external vendors, including CROs, labs, and other service providers.
• Negotiate contracts and ensure vendors meet project deliverables and quality standards.

Stakeholder Engagement:

• Serve as the primary point of contact for internal and external stakeholders on clinical operations matters.
• Prepare and present regular updates to senior management on the status of clinical trials.

Requirements

• Bachelor's degree or higher in a relevant scientific discipline.
• At least 10 years of relevant experience in clinical operations, including previous experience working in a pharmaceutical company.
• Experience with site monitoring.
• Experience with CNS trials.
• Experience with psychedelic trials Preferred.
• Experience with global regulatory submissions (e.g., EMA)
• Experience managing a team of clinical operations staff.
• Proficiency in resource planning and financial management (clinical trial budgeting).
• Deep working knowledge of GCP, ICH guidelines, and FDA regulations.
• Well-organized and detail-oriented, with strong written and verbal communication skills.
• Skilled in collaborating with internal and external cross-functional teams, vendors, and scientific and clinical advisors.
• Effective process and project management skills.
• Ability to travel 25% of the time.

#directorclinicaloperations #clinicaltrials #cro #cns #psychedelictrials #clinicaloperations #regulatorycompliance #hiring #lifesciences #neuroscience

Position Overview: The Supply Chain Manager will oversee the end-to-end management of international shipments, ensuring the efficient and compliant movement of medical devices and administration sets. This role requires a strategic approach to planning, supplier management, and logistics coordination, focusing significantly on regulatory compliance and maintaining effective communication with international partners.

Mandarin proficiency is crucial for interacting with Chinese suppliers and partners.

Mandarin Language Proficiency:

• Utilize Mandarin language skills to effectively communicate with Chinese-speaking suppliers, partners, and stakeholders.
• Translate and interpret supply chain documentation and communications as needed.

Responsibilities:

• Oversee procurement processes for medical devices and components, working closely with Chinese suppliers to ensure quality and timely delivery.
• Negotiate terms with international suppliers and establish strong relationships to support supply chain efficiency.
• Monitor supplier performance and address issues to maintain high quality and compliance standards.
• Implement and track logistics KPIs to measure performance, identify bottlenecks, and drive continuous improvement.
• Ensure coordination between internal teams and external logistics partners to meet delivery schedules and service levels.
• Develop and manage inventory strategies to balance stock levels of medical devices and administration sets, minimizing excess inventory and shortages.
• Monitor inventory turnover and adjust supply plans to ensure alignment with
• Ensure all international shipments comply with FDA regulations and other relevant international standards for medical devices.
• Prepare for FDA audits by maintaining accurate documentation and records of international shipment activities.
• Develop and execute strategies for efficiently managing international shipments, ensuring timely delivery of medical devices and administration sets.
• Coordinate with international freight forwarders, customs brokers, and logistics providers to optimize shipment processes and reduce lead times.
• Collaborate with R&D, Quality Assurance, Regulatory Affairs, and Sales teams to align international shipment activities with product requirements and business goals.
• Address and resolve any supply chain-related issues in coordination with cross-functional teams.

Requirements:

• Education: Bachelor’s degree in Supply Chain Management, Business Administration, Logistics, or a related field. Master’s degree or relevant certifications (e.g., APICS, CPIM) are a plus.
• At least 5 years of experience in supply chain management with a focus on international shipments, preferably in the medical device industry.
• Strong understanding of international logistics, procurement, and regulatory compliance.
• Fluent in Mandarin (both written and spoken) and English, with proven ability to communicate with Mandarin-speaking partners and stakeholders.
• Strong understanding of international logistics, supply chain management, and regulatory compliance, especially in the medical devices sector.
• Experience with FDA regulations and audit preparation for medical devices.
• Excellent analytical, problem-solving, and decision-making skills.
• Proficiency in supply chain management software and tools (e.g., ERP systems).
• Experience with web-based CRMs such as Salesforce.com.
• Ability to create simple to elaborate Excel-based reporting tools.
• Effective communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
• Ability to thrive in a fast-paced, regulated environment and manage multiple priorities.

#Mandarin #MedicalDeviceManufacturing #Medical Devices #Supply Chain Management #Demand Planning #Supplier Performance #Regulatory Affairs #Hiring #NewPosition #ExecutiveRecruitment

Position Overview: The Complaint Vigilance Specialist is pivotal in ensuring the seamless execution of the complaint-handling process. With the help and direction of peers and management, this position involves executing various stages of the complaint lifecycle, including feedback review for Complaint/Non-Complaint determination.

Responsibilities:

• Review and analyze customer feedback, ensuring meticulous attention to detail.
• Customer follow-up, complaint initiation, processing, evaluation and investigation, coding, MDRs, and documentation of customer complaints.
• Conduct thorough investigations into customer complaints, adhering to regulatory guidelines.
• Collaborate with Customer Service and Operations teams to facilitate the complaint-handling process.
• Initiate and process MDR filings for the FDA, demonstrating a comprehensive understanding of regulatory requirements.
• Document all stages of customer complaints, maintaining accurate records for compliance purposes.
• Act as a liaison between internal teams and regulatory bodies to ensure alignment with standards.
• Report directly to the Director Complaint Vigilance, providing regular updates on complaint-handling activities.

Requirements:

• Bachelor’s degree in a scientific discipline preferred.
• Minimum 2 years of experience in medical device complaint handling, focusing on  FDA regulations.
• Proven track record of meticulous attention to detail in previous roles.
• Strong communication and interpersonal skills, with the ability to collaborate effectively.
• Self-motivated individual with a proactive approach to problem-solving.
• Computer proficiency and web-based tools like Microsoft Teams, Salesforce, Excel, and Google Docs.
• Effective verbal and written communication, including phone calls, emails, and chat.
• Familiarity with MDR filing processes and requirements for the FDA as per 21CFR820 and 21CFR803 preferred.
• Knowledge of ISO13485 and ISO14971 preferred.

#complainthandling #complaintvigilance #medicaldevice #fda #mdr #hiring #newposition #executivesearch #lifesciences

My client is seeking a highly experienced Senior Quality Manager to join their team and lead the maintenance and continuous improvement of our Quality Management System (QMS) in compliance with all applicable regulations and standards for medical devices. The successful candidate will be instrumental in ensuring that our products meet the highest quality standards and regulatory requirements.

Responsibilities:

• Lead and manage Quality Engineers, Specialists, and Inspectors by providing direction, mentorship, and growth opportunities.
• Reporting on the performance of the quality management and proposing recommendations to improve the system to Senior Management.
• Vendor approval and monitoring.
• Manage the complaint handling system, including investigation, root cause analysis, and corrective actions. Monitor and analyze trends to identify areas for improvement.
• Develop and implement quality plans that align with company objectives, including risk management, validation activities, and product release criteria.
• Support, as needed, regulatory assurance, engineering, and Senior Management with regulatory filings, creation of technical files, vigilance/incident reports, internal and external audits, and sign-off for relevant documents.
• Corrective and preventive action system (CAPA), internal quality audits, non-conforming materials, and incoming and final inspection.
• Conduct product design control activities for new and sustaining product development efforts.
• Support risk analysis activities, including design and process FMEA.
• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
• Support manufacturing engineering in creating DMR, DHR, routers, bills of material, and specifications for in-house and external manufacturing.
• Conduct Internal Audits of the Quality System.
• Prepare for and participate in audits by external organizations, such as FDA, Notified Bodies, etc.

• 10-15 years of experience in medical device quality assurance is required.
• A minimum of 5 years of hands-on management experience is required.
• Bachelor’s degree in scientific, biomedical, or engineering discipline is required.
• Extensive experience in quality management within the medical device industry.Solid understanding of applicable regulations, including FDA 21 CFR Part 820, ISO 13485, Health Canada MDD’s, and European MDR’s.
• Experience in directly supporting manufacturing.
• Strong leadership and project management skills.
• Strong oral, written, and interpersonal skills required for interaction within the organization and external customers.
• Hands-on and results-oriented, with the ability to multitask.

#medicaldevice #qualitycontrol #medicaldevicequalityassurance #capa #audit #complaintmanagment #qualityauditing #qms #qualitymanagmentsystems #non-conforming

Consulting Position Long-term

Position Overview: The RA/QA Consultant is responsible for all activities involving quality assurance and compliance within the Company’s quality management system and domestic and international regulatory requirements. The consultant will oversee all quality activities while providing strategic direction and tactical execution. The consultant will maintain quality systems and processes, including developing design control, training, risk management, document control, and maintenance of the Device Master File.

Responsibilities:

• Lead design control implementation and adoption through preclinical and clinical activities.
• Develop and execute US Regulatory Strategies for product development and submissions.
• Act as a liaison between the Company and FDA, respond to inquiries and requests for information.
• Lead the planning and implementation of risk management efforts.
• Lead the development and execution of vendor selection, specification drawings, quality agreements, and verification and validation protocols.
• Experience with the creation of V&V protocols and test reports.
• Ensure that the Quality Management System is established, implemented, and maintains its effectiveness in accordance with applicable standards.
• Maintain and review documentation for quality and regulatory impact as required by regulatory agencies and internal customers.
• Develop and implement effective training programs to achieve and maintain quality system and regulation awareness, ISO certifications, and compliance.
• Establish key quality metrics and annual quality goals; prepare trending reports for the quarterly management review meetings.
• Develop post-market and internal assessment processes for the organization, including CAPA, complaint handling, and field action.

Qualifications:

• Experience with 510(k) submissions and PMA applications is required.
• Undergraduate degree in engineering or a scientific or technical discipline is required.
• 7+ years of quality & regulatory medical device experience industry experience required.
• Experience in the development, implementation, maintenance, and ongoing support of the Quality Management System, including document creation and revision to SOPs, forms, and work instructions.
• Demonstrated proficiency with quality system procedures and medical device directives, including 21 CFR 820 and related international standards.
• Experience interacting with the FDA, Notified Bodies, and other regulatory agencies.
• Class III Premarket Approval (PMA).
• Ability to work effectively in a team environment and on cross-functional teams.

#medicaldevice #510(k) #PMA #QMS #designcontrol #qualityassurance #consulting #contractor #capa #contracting #regulatoryaffairs

Onsite Position Located in MA

The Senior Compliance Engineer will ensure products comply with standards and regulatory requirements (Safety, EMC, EMI) in worldwide markets.

Responsibilities:

• Monitor the status of relevant international standards and provide guidance on present and future regulatory testing requirements.
• Support pre-compliance testing and mitigation of new and modified designs.
• Interact with third-party test houses that conduct compliance testing. This includes the creation of EMC test plans, checklists, documentation packages, on-site test support, test report reviews.
• Support risk analysis activities, including risk management plans, hazard analysis, FMEA, and risk management reports.
• Assist regulatory department with FDA, CE, and other regulatory submissions.

Requirements:

• Bachelor's Degree in scientific or engineering field; electrical engineering is preferred.
• 10+ years of experience with development and compliance testing of Class II electro-mechanical medical devices.
• Knowledge of standards and regulations such as ISO 14971, IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-22, 60825-1, 62366, 62304, ETSI EN 301 489, 21 CFR 1040.10, 1040.11
• Knowledge of Design Controls, regulations, and standards such as FDA QSR's and ISO 13485 is preferred.
• Knowledge of EMC/EMI mitigation techniques is preferred.
• Supporting medical device compliance testing (e.g. EMC, EMI, and Safety) with external test houses, such as TUV and Intertek, including EMC Test Plans, Safety Checklists, and documentation packages.
• Knowledge of technical design and risk management documentation, including design specifications, verification/validation protocols, risk management plans, hazard analysis, FMEA, and risk management reports.
• Demonstrated capability to work on multiple programs on cross-functional program teams and be an expert relative to product standards and regulatory requirements.
• Experience with lasers and optical technologies is preferred but not necessary.
• Strong working knowledge of Microsoft Word and Excel.

#medicaldevice #complianceenginner #classII #electromechanical #emc #emi #testhouses #iso #iec #newjobalert

Retained Search

Must be within a commutable distance of the Greater Boston area or willing to relocate.

Our client is at the forefront of the healthcare industry, providing innovative and comprehensive solutions for hospitals. Their focus is developing and commercializing medical devices, software, and services, improving healthcare delivery, and enhancing patient outcomes.

Position:  The Director of Quality Assurance will be instrumental in defining Quality Management goals and ensuring alignment with my client's other relevant business targets. In this role, you will be the point of contact with notified bodies while leading a team of Quality Professionals.  

Responsibilities:

• Maintain compliance and continuously improve QMS for ISO 9001, ISO 13485, MDD 93/42EEC, MDR 2017/745, and 21 CFR Part 820 and further regulatory requirements that apply to the product portfolio.
• Serve as the focal point of contact with the Notified Bodies, including delegate PRRC.
• Serve as the delegate point of contact for FDA, TÜV, regulatory, and third-party audits and inspections and/or preparation as necessary.
• Responsible for supporting Product Quality, Complaint Review, and QMS Boards.
• Analyzes and reviews quality management goals and breaks down corresponding goals for the relevant product quality targets.
• Defines Quality Management goals and ensures alignment with other relevant business goals.
• Manages the Post-Market Surveillance Team and the requirements of 21CFR 803, 806, and 820.198, as well as other country regulations as required.
• Monitors and reviews CAPA implementation and closures.
• Participates in internal audits as part of the yearly audit program.
• Assures effective Quality System compliance within each CFT, Product Steering Board, and Product Quality Board.
• Responsible for the lifecycle (hiring, developing, retaining) of direct reports. Coach and guide individual contributor staff. Manages the performance of the team.

Requirements:

• Bachelor's Degree in a scientific discipline, life sciences, biomedical or other engineering science - Master's or a PhD (desired).
• Minimum of 10 years experience in a Quality Leadership role in the medical or device industry with at least 5 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.
• 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.
• Ability to develop and manage an integrated QMS; to lead multi-level and multi-discipline work teams to develop, implement, and manage processes/business systems.
• Preferred experience managing both quality and regulatory.
• Strong interpersonal and communication skills and the ability to persuade and influence others at all levels within the company.
• Proven track record in applicable disciplines of ISO 9001, ISO 13485, 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.
• Sound people management and change management experience.

#medicaldevice #qualityassurance #qms #teamleadership #boston #newposition #director #audits #executivesearch #retained

Onsite Position Located in MA

My client seeks a Design Assurance Engineer for Class II electro-mechanical medical devices. In this role, you will ensure that the products meet regulatory and quality requirements throughout the design and development process. This involves collaborating with cross-functional teams to verify and validate the design outputs against user needs and regulatory requirements.

Responsibilities:

• Conduct product design control activities for new and sustaining product development efforts.
• Support risk analysis activities, including design and process FMEA.
• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
• Support Design Engineering in the creation of Design History and Technical Files.
• Interact with third-party test houses that conduct compliance testing of IPG products.
• Assist the regulatory department with FDA, CE, and other regulatory submissions.
• Perform all other essential duties as assigned.

Requirements:

• Bachelor's Degree in scientific or engineering field; electrical engineering is preferred.
• 2-5 years of experience with engineering and development of Medical Devices,
• Class II electro-mechanical medical devices experience preferred.
• Knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSR's, ISO 13485, ISO 14971, 60825, 62366, and 62304, is preferred.
• Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV and Intertek.
• Maintenance of technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA.

• Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power, and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred.
• Experience with lasers and optical technologies desired but not necessary.
• Strong working knowledge of Microsoft Word and Excel.

#medicaldevice #electromechanical #designassurance #devicehistory #qualityassurance #classII #lasers #newposition #electro-mechanical

My client seeks a highly motivated Director of Regulatory Affairs to join their growing organization. In this role, you will be responsible for all activities to lead and maintain global regulatory approvals to market devices throughout the product development lifecycle while building and managing a regulatory team.

Position located in MA. Must be in MA or willing to relocate.

Responsibilities:

• Develop strategies for regulatory approval of medical devices worldwide based on business needs.
• Organize project teams, initiate project schedules, and provide project leadership worldwide to achieve desired regulatory outcomes within defined timeframes.
• Prepare global regulatory applications, including US medical submissions (pre-submissions, 510ks, IDEs, and annual reports) and EU MDR, and design dossiers and technical files for other international markets.
• Interact with the US FDA and other regulatory authorities worldwide.
• Manage reporting to the FDA (MDRs) and Vigilance Reports; participate in the Complaint System.
• Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
• Participate in Risk Management assessments.
• Review design and manufacturing changes for compliance with applicable regulations.
• Oversee and prepare documentation to support the Clinical Evaluation Report to ensure accuracy, applicability, consistency, and control of regulatory documents.
• Support quality system audits by notified bodies, government agencies, and customers.
• Assist with environmental regulations and standards (e.g., RoHS, REACH, etc.).
• Hire, mentor, and train regulatory staff; engage outside contractors as needed.
• Perform all other essential duties as assigned.

Requirements:

• Must have experience with programmable electro-mechanical and sterile medical devices.
• Bachelor's degree, preferably in an engineering or life sciences discipline, advanced degree preferred.
• 10+ years of regulatory experience with US and international submissions.
• Demonstrated aptitude for preparing and submitting 510(k)'s and international design dossiers for new products.
• Medical Laser experience preferred.
• Prior interaction with the FDA and other worldwide agencies is required.
• Hands-on knowledge of all phases of Design Controls and Risk Management practices, regulations and standards, including FDA QSR's, ISO 13485, 14971, 10993, 11607, 14644, 14698, 15223, 11135, 11138, 11737, 17665, and 22442, and IEC 60601, 60825, 62304, and 62366.
• Experience in building and managing regulatory teams and leading cross-functional project teams on collaborative projects.
• Strong working knowledge of Microsoft Word and Excel.

#medicaldevice #regulatorystrategy #director #medicallaser #electromechanical #newposition #steriledevices #classII #electro-mechanical #npd

Location - Hybrid Position Greater Boston

Our client is a commercial-stage pharmaceutical company committed to developing and commercializing therapeutics to help improve patients' lives with severe eye disorders. With approved products and a robust pipeline, this is the perfect time to join this growing team.

Overview: In this high visibility role, you will report directly to the Chief Regulatory Officer. The Director of Regulatory Affairs Strategy will be responsible, in alignment with the CRO, for assisting in designing regulatory strategies during the development and life-cycle management of assigned programs. In this role, you will act as the primary regulatory liaison with the US FDA and work closely with the Global Clinical Research Organization and ex-US consulting firms to coordinate the execution of established regulatory submission plans.

Responsibilities:

• Assists the Chief Regulatory Officer (CRO) in designing and implementing regulatory strategy plans for assigned products/projects, form development, and throughout the life cycle of the dossier/product.
• Working closely and collaboratively with Regulatory Operations and Regulatory CMC, this is a 'hands-on' position where an individual must be versatile and capable of managing the operational workload and strategy execution.
• Interfaces directly with the US FDA and acts as primary liaison.
• Authoring health authority responses alongside subject matter experts and submission deliverables.
• Manage the routine maintenance of open regulatory applications, emphasizing high-quality, timely submissions to Regulatory Agencies, submission activities initial IND, NDA.
• Coordinates with Regulatory Operations and Regulatory CMC.
• Works closely with CRO to prepare and facilitate informal and formal regulatory meetings aligned with established regulatory and development strategies.
• Participates actively and assists CRO in the Advertising and Promotional Review and submission (FDA 2253) process.
• Works with functional groups to ensure documents adequately support the established regulatory strategies.
• With minimal supervision, manage routine development and post-approval regulatory activities.
• Maintains working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
• Archives and maintains regulatory submissions, correspondence, and other regulatory documents in compliance with regulatory requirements and SOPs.

Qualifications:

• BA/BS degree in life sciences discipline, Master of Sciences in Regulatory Affairs is highly desirable.
• At least 5-7 years of pharmaceutical industry experience, of which at least 4 years of Regulatory Affairs strategy drug development experience.
• Experience and knowledge in preparation of INDs, NDAs, and supportive amendments or supplements.
• Working knowledge of eCTD elements and structure, ICH standards, and submission requirements.
• Experience with small molecules and drug-led-device combination products preferred.
• Ophthalmic Therapeutic experience preferred
• Experience in Clinical Trial Authorization Applications in Canada, EU, and other regions/countries is preferred.
• Experience with eCTD (US and ex-US) and using Regulatory Information Management System preferred.
• Strong communication and regulatory writing skills.
• Proficient in MS Word and Adobe Acrobat Pro applications and use of eCTD templates.
• Ability to balance multiple tasks to meet priorities and timelines.

#hybrid #lifesciences #pharmaceutical #smallmolecule #combinationproducts #regulatoryaffairs #drugdevelopment #ophthalmic #executivesearch #boston