Regulatory Affairs Consultant
Remote · United States
Job Summary
Regulatory Affairs Consultant with global OUS regulatory expertise for Class III implantable medical devices. Lead and support regulatory strategy and execution for international markets (EU MDR, Japan PMDA/MHLW, China NMPA, Brazil ANVISA). Provide regulatory guidance throughout the product lifecycle, review and manage international submissions, collaborate cross-functionally with R&D, Clinical, Quality, Manufacturing, and Marketing, and interface with notified bodies and regulatory authorities to support market expansion. Remote consulting engagement based in the United States.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related discipline. Advanced degree preferred.
- 8+ years of regulatory affairs experience within the medical device industry.
- Strong hands-on OUS regulatory experience supporting Class III implantable medical devices.
- Required experience with EU MDR submissions and regulatory strategy.
- Strongly preferred experience supporting: Japan PMDA/MHLW submissions, China NMPA submissions, Brazil ANVISA registrations.
- Experience interacting directly with notified bodies and international regulatory agencies.
- Knowledge of global regulatory requirements for high-risk implantable devices.
- CNS product experience and/or subcutaneous injection device experience strongly preferred.
- Combination products regulatory experience is a plus.
- Familiarity with ISO 13485, ISO 14971, EU MDR, and applicable international standards/regulations.
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