Regulatory Affairs Consultant
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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
- Bachelor’s degree in a scientific or engineering discipline (advanced degree preferred).
- Minimum 7+ years of regulatory affairs experience in the medical device industry.
- Proven track record with successful US and international submissions for Class II/III devices.
- Strong working knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and MDR/IVDR requirements.
- Experience with combination products, software as a medical device (SaMD), or IVDs a plus.
- Excellent organizational, communication, and problem-solving skills.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
Details
- Seniority level: Mid-Senior level
- Employment type: Contract
- Job function: Regulatory Affairs
- Industries: Medical Equipment Manufacturing
Location: San Diego, CA. Salary: $145,000.00–$165,000.00 per year.
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