Director Regulatory Affairs

A well-established medical device organization is looking for a Director of Regulatory Affairs. The Director of Regulatory Affairs will provide their regulatory expertise to develop and implement strategies in order to gain approvals/clearances for IDE's, 510(k)'s, PMA and international submissions. Responsibilities include: * Developing and implementing regulatory strategies for class II and III medical devices. Submissions include IDE's, 510(K)'s and PMA's * Interact with FDA and other health agencies * Prepare and submit domestic and international submissions including 510(k)'s, PMA's, IDE's, Tech Files, and other international submissions * Manager relationship and communication with international regulatory agencies * Collaborate with foreign organizations to gain global approvals Qualifications: * 5-10 Years Medical Device Regulatory Experience * B.S. Degree * Expertise in domestic and international regulatory submissions/strategies * Expertise in numerous therapeutic areas highy desired

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