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REGULATORY SERVICES GROUP

MDCI has the following open positions in our Regulatory Services Group, which supports clients through the development and implementation of regulatory strategies to gain marketing authorization for medical devices in the U.S. and internationally.

REGULATORY STAFF CONSULTANT

This position reports to the Director of Regulatory Services, with the following principal responsibilities:

• Assist clients in meeting FDA requirements and securing FDA approval or clearance for the introduction and marketing of medical devices.
• Write, edit, and prepare submissions for client devices, such as IDEs, PMAs, 510(k)s, and other formal and informal communications with the FDA.
• Collaborate with clinical services group to prepare applications (i.e., IDEs) for conducting clinical investigations in the U.S., Canada and EU countries. Generate required submissions and progress reports to support clinical studies.
• Assure best practices, conformance to regulatory requirements, operational excellence and quality.

Qualified candidates will have a minimum of 3 to 5 years progressive regulatory affairs experience, currently in a position with demonstration of writing 510(k)s. Candidates must have in vitro diagnostic experience; good working knowledge of all aspects of Food and Drug law and relevant medical device regulations. B.S. in engineering, sciences, or medical field required. RAC preferred. Excellent oral and written communication skills and attention to detail required.

Position is offered in either MDCI office (San Diego, CA or North Attleboro, MA)