This is a remote contract opportunity to join a small commercialized medical device company as they go through 3 510k submissions over the next 12-18 months.
Main Responsibilities
- Prepare and write the 510(k) submissions, Technical Files/Documentation, and documentation for U.S. registrations.
Experience Required
- A Bachelor's, Masters, or PhD in Chemistry is required.
- 5 years' Regulatory Affairs experience in the Medical Devices space, with multiple successful 510k submissions.