Location: Plymouth, MN, US
Job Summary:
Job Duties
- Develop and execute regulatory strategies for medical devices.
- Prepare and coordinate regulatory submission documents (e.g., 510(k), IDE).
- Monitor regulatory compliance and interpret guidance documents.
- Provide regulatory expertise to cross-functional teams.
- Interact with regulatory agencies as needed.
Required Skills
- Strong knowledge of medical device regulations.
- Excellent decision-making and negotiation abilities.
- Strong analytical, planning, and organizational skills.
- Exceptional verbal/written communication and presentation skills.
- Ability to manage priorities and work independently or collaboratively.
Required Experiences
- Bachelor's degree with 5+ years or an advanced degree with 3+ years in medical device regulatory affairs.
- Experience with complex regulatory submissions.
- Prior program or people management experience preferred.
Job URLs: