About the role
The team manages regulatory submissions for medical devices and in vitro diagnostics. The specialist prepares and executes regulatory strategies for domestic and international markets. This involves developing submission documents, interacting with agencies, and ensuring product development aligns with regulatory requirements.
Our summary of the posting; the original is on the Natera careers page.
What the posting requires
- Required
- Security clearance
- Submission strategy
- Risk assessment
- 510(k)
- International regulatory
- Regulatory data
- Product release documents
- Clinical protocols
- Clinical study monitoring
- Preferred
- Project management
- Biological sciences degree
- Chemistry degree
- Related science degree
These tags are our reading of the posting. They can miss something; the original posting is the reference.