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Regulatory Affairs Specialist
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Full-time
- ATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California.
- The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; as well as the support of daily activities related to product design teams, change control, and regulatory product submissions.
- Assists with post-market surveillance evaluation, trending, and reporting, including updates to risk management (FMEA) process.
- Reviews and approves labeling and promotional materials for compliance with applicable regulations and policies.
- Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc
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