Regulatory Affairs Lead
Regulatory Affairs Lead
Position Summary
The Regulatory Affairs Lead will provide strategic and operational regulatory support across the product lifecycle for Class III medical devices. This role will partner cross‑functionally to help ensure regulatory alignment, support global submissions, and maintain compliance with applicable regulations.
Key Responsibilities
- Lead and support regulatory strategy for complex, high‑risk medical devices throughout development, submission, and post‑market activities.
- Contribute to the planning, preparation, and execution of regulatory submissions for Class III devices.
- Serve as a regulatory liaison with internal stakeholders, supporting engineering, clinical, quality, and manufacturing teams as needed.
- Review and guide technical documentation to ensure regulatory requirements are adequately addressed.
- Monitor evolving regulatory requirements and assess potential impacts to ongoing and future programs.
- Support interactions with regulatory authorities and notified bodies, as appropriate.
- Provide regulatory input into design changes, risk management activities, and product lifecycle decisions.
- Maintain awareness of international regulatory frameworks and standards relevant to Class III devices.
Qualifications
- Bachelor's degree in a scientific, engineering, or related discipline; advanced degree preferred.
- Significant experience in regulatory affairs within the medical device industry.
- Demonstrated experience with Class III medical device submissions strongly preferred.
- Working knowledge of U.S. and international medical device regulatory requirements.
- Ability to operate effectively in a fast‑paced, matrixed environment.
- Strong communication and collaboration skills, with the ability to influence across functions.
Preferred Experience
- Participation in PMA or equivalent high‑risk device submissions.
- Experience supporting products from development through approval and commercialization.
- Background working in highly regulated environments with complex technologies.
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