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 glob...