Zimmer Biomet·4 days ago
4 days ago
Regulatory Affairs Manager
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What you'll do
- Develop and execute regulatory strategies supporting business objectives
- Ensure compliance with US FDA and international standards
- Act as the primary liaison with regulatory authorities
- Collaborate with cross-functional teams
What they're looking for
- Significant experience in medical device regulatory affairs
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
We are seeking a Regulatory Affairs Manager to develop and execute regulatory strategies supporting business objectives, ensuring compliance with US FDA and international standards. The role involves acting as the primary liaison with regulatory authorities and collaborating with cross-functional teams. Ideal candidates have significant experience in medical device regulatory affairs.
Skills
- regulatory strategy
- fda regulations (21 cfr part 820)
- medical device compliance
- us 510(k)
- iso 13485
- iec 60601 standards
- post-market surveillance
- labeling compliance
- ce mark (eu mdd/mdr)
- project management
- cross-functional collaboration
- human factors standards
- labeling knowledge 15223-1
- regulatory documentation
- product development processes
- regulatory correspondence
- stakeholder management
- training and mentoring
- microsoft office
- budget tracking
- kpi identification
- regulatory affairs certification (rac)
Company
Zimmer Biomet
San Diego, United States of America
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