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Regulatory Affairs Manager
Ref No.: 18-10353
Location: Lexington, Massachusetts
Start Date / End Date: 08/07/2018 to 08/06/2019
Serve as the lead device regulatory affairs member of project development teams, primarily focused on (but not limited to) device products. Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development. Specifically, supporting all device labeling activities, packaging and their regulatory content, IFU development and coordinating labeling deliverables with device QA.

Develop regulatory submission strategies in agreement with defined product development objectives. Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned device projects. Prepare and submit device content for IND and NDA applications, or author 510K, and CE Mark regulatory filings. Minimum of 5 years + experience in device development and registration activities, including personal management of an approved devices from initial development through to approval and market launch. Prior project management experience a plus, with a demonstrated capability to lead and motivate staff is essential. Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical.