Regulatory Affairs Specialist – Medical Device

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.

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