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.

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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.

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