Insulet is looking for an experienced Director of Regulatory Affairs.

This position is integral to the new product development aspects of the business through the development of regulatory strategies and coordination of submissions. Clinical outcomes are imperative to the success of the company and require appropriate design and regulatory compliance to assure full utilization for clincial justifications, labeling claims and marketing efforts. Mature product requires continued support and monitoring through Quality System compliance audits, Medical Device Reporting, and labeling changes.

Insulet is seeking a team orientated leader with a minimum of 10 years experience in the medical device regulatory field as well as prior experience with PMA and clinical trials. In addition this person should have prior experience with Class ll or lll medical devices.