Regulatory Affairs Consultant

We are seeking an experienced Medical Device Regulatory Consultant to support regulatory strategy, submissions, and compliance activities for Class II and / or Class III devices. This role will collaborate closely with cross-functional teams, ensuring products meet FDA and international regulatory requirements from development through commercialization.

Responsibilities

• Develop, review, and execute regulatory strategies for new and existing medical devices, including US FDA, EU MDR / IVDR, and other international markets.
• Prepare, compile, and submit regulatory submissions (e.g., 510(k), PMA supplements, IDEs, Technical Documentation, Design Dossiers).
• Advise on regulatory requirements for product development, manufacturing changes, labeling, marketing claims, and clinical activities.
• Assess the regulatory impact of design changes, manufacturing modifications, and process improvements.
• Monitor and interpret changes in global regulations and standards, providing guidance to internal teams.
• Support and lead interactions with regulatory agencies, including FDA, Notified Bodies, and other authorities.
• Ensure all documentation is accurate, complete, and compliant with applicable regulations.
• Train and mentor internal teams on regulatory processes and best practices.

Qualifications

Details

Location : San Diego, CA. Salary : $145,000.00–$165,000.00 per year.

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