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Regulatory Affairs Specialist
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$92,600 - $112,700
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.
- Essential Duties and Responsibilities Collaborates as a core team member on new product development teams.
- 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.
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