Job Title
Pay Range: $51.45hr - $56.45hr
Requirement/Must Have:
- Must have 7+ years of experience in Medical Device Regulatory Affairs.
- Working knowledge in US Medical Device Submissions.
- Highly experienced with regulatory change assessments.
Responsibilities:
- Ensure timely approval of new medical devices and continued approval of marketed products.
- Participate in continuous improvement activities, product plan development and implementation, regulatory strategy, risk management, regulatory policy and intelligence.
- Serve as regulatory representative to cross-functional teams.
- Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
Skills:
- Regulatory change assessments.
- US Medical Device Submissions.
- Regulatory strategy.
- Risk management.
- Regulatory policy and intelligence.
- Technical labeling.
Qualification And Education:
- 7+ years of experience in Medical Device Regulatory Affairs.