Regulatory Affairs Director
Company Summary:
My client, a reputable medical device company located in Marlborough, MA is seeking an experienced and driven Director of Regulatory Affairs. Their focus is on developing innovative laser devices and amplifiers. They are looking for this person to come in on a hybrid basis!
The Regulatory Affairs Director will be responsible for:
- Developing Regulatory strategy for approval of medical devices worldwide.
- Preparing global regulatory submissions including 510ks, IDEs, annual reports, EU MDR, and design dossiers for other international markets.
- Interacting with the FDA and other global regulatory authorities.
The Regulatory Affairs Director should have the following qualifications:
- Bachelor's degree and 10+ years of regulatory experience with US and international submissions.
- Demonstrated ability to author 510ks and other international dossiers.
- Previous interaction with the FDA/worldwide agencies.
