Senior Regulatory Affairs Specialist / Manager
My client, a leading medical device company specializing in radiation treatments for cancer patients, is looking to add a Senior Specialist / Manager to their regulatory team! This role will be based in Littleton, MA.
The Senior Regulatory Affairs Specialist / Manager will be responsible for:
- Providing analysis and official recommendations based on updated regulations, laws, and standards that may apply to the company
- Ensuring adequate compliance schemes associated with regulatory compliance systems
- Authoring and maintaining all regulatory product submissions
- Preparing IDE, 510(k), PMA, and other regulatory filings
- Communicating with the FDA and other regulatory agencies regarding regulatory submission strategy and approval reviews
- Developing and implementing regulatory strategy for new technologies and product modifications
The Senior Regulatory Affairs Specialist / Manager should have the following qualifications:
- Bachelor's degree with 5 - 10 years of relevant experience
- Experience with EU MDR, FDA 510(k), and other medical device skillsets
- Experience with complex medical devices and post-market surveillance preferred
- Excellent written and verbal communication skills
If you are interested in this position, please apply today and do not hesitate to contact me with any questions!