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Associate Director of Regulatory Affairs

A Class III implantable medical device company is seeking an experienced Regulatory Affairs Professional to join their team. The Associate Director will develop and lead the company's global Regulatory strategy. This is a rare opportunity to join a growing company with a mission on improving patients lives through their unique products.

Responsibilities:

~Prepare & lead FDA submissions; IDEs, 510(k)s, PMAs, etc.

~Strategize timely approvals from clinical trials through product release

~Work directly with regulatory bodies to ensure submission approval both domestically & internationally

~Work & support cross-functional teams (R&D engineers, technical experts, etc.) to ensure appropriate standards are met

~Support compliance and audit registrations, i.e. ISO 134685

Qualifications:

~Bachelor's Degree - B.S. in a Life Science; M.S./PhD preferred

~10+ years experienced in Regulatory Affairs (Medical Device)

~Experience with Class III implantable devices

Sthree US is acting as an Employment Agency in relation to this vacancy.