Senior Regulatory Affairs Specialist
Role Summary
The Senior Regulatory Affairs Specialist will support the development and execution of global regulatory strategies for medical devices and combination products. This role is responsible for preparing regulatory submissions, maintaining product registrations, supporting product lifecycle activities, and ensuring compliance with applicable global regulatory requirements. The position requires close collaboration with cross-functional teams including R&D, Quality Assurance, Clinical Affairs, Manufacturing, Supply Chain, and Marketing.
Key Responsibilities
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Support the development and implementation of regulatory strategies for medical devices and combination products across global markets.
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Prepare, compile, review, and maintain regulatory submissions including FDA 510(k), PMA, De Novo, EU MDR Technical Documentation, and international registration dossiers.
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Perform regulatory impact assessments for product design changes, manufacturing changes, software updates, supplier changes, process changes, and labeling revisions.
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Support product lifecycle management activities by maintaining regulatory compliance and global market registrations.
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Prepare and maintain Technical Documentation, GSPR checklists, compliance matrices, and regulatory evidence packages.
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Review and update product labeling, Instructions for Use (IFUs), packaging artwork, UDI requirements, and marketing materials to ensure regulatory compliance.
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Support regulatory activities during product development, design reviews, risk management, verification and validation activities, and change control processes.
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Support regulatory strategy and documentation activities for combination products.
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Prepare documentation packages for internal audits, supplier audits, notified body audits, and regulatory inspections.
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Maintain regulatory databases, submission trackers, product registration records, and compliance documentation systems.
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Conduct regulatory research and support assessment of evolving regulatory requirements.
Qualifications & Experience
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Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, or related discipline.
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5+ years of experience in Regulatory Affairs within the medical device or combination product industry.
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Experience preparing regulatory submissions and technical documentation for global markets.
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Working knowledge of FDA regulations, EU MDR requirements, and international medical device regulations.
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Experience with regulatory change assessments, product registrations, and lifecycle management activities.
Required Skills
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Strong understanding of medical device regulatory requirements and submission processes.
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Knowledge of standards including ISO 13485, ISO 14971, IEC 60601-1, ISO 20417, and ISO 15223-1.
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Strong technical writing, documentation review, and analytical skills.
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Ability to manage multiple regulatory activities and meet timelines.
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Strong collaboration and communication skills with cross-functional teams.
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Attention to detail with strong compliance mindset.
