Group Director, Regulatory Affairs 1275

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Contact Information: Global Medical Device Company Memphis, TN

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Reference Number: lddr1855866 Job Description: Our client is a global medical device company with operations in 35 countries. The company markets clinically superior products, principally in orthopaedics, endoscopy, and advanced wound management. Our client is seeking a qualified candidate to adhere to United States and international regulatory agency requirements including coordinating and managing the development, authoring, and publishing of registrations and submissions to these agencies.  Responsibilities include:  preparing of U.S. FDA and international submissions as they apply to products; evaluating and developing regulatory product approval strategies and judgments; keeping abreast of current and emerging regulations, standards, guidance, and best practices for medical devices; labeling and marketing material compliance and translations; device complaint handling, adverse event reporting, remedial action, and related regulatory reporting; directing and overseeing the work of regulatory employees.   Successful candidates MUST have these minimum capabilities to be considered for this position:  BS degree with 7 years of regulatory affair experience or MS, PhD, or MD degree with 5 years of direct responsibility for regulatory affairs; experience with Class III medical device submissions and PMA submissions required; extensive knowledge of FDA and international laws, regulations, and guidelines as well as in depth experience in dealing with FDA and international medical device regulatory agencies necessary; excellent written and verbal communication skills a must; 10%-20% travel required. Experience Level: Unspecified Requirements:
Location: Memphis TN Duration: Direct Placement Pay Rate: $150K - $160K	Similar Jobs   Lake Bluff, IL   Regulatory Affairs Project Manager-Pharma   Malvern, PA   Senior Regulatory Affairs Specialist - Medical Device   Salt Lake City, UT   Associate Product Manager/Marketing/Branding- Medical Device   Bridgewater, NJ   Medical Reviewer   San Francisco, CA   Senior Product Manager/Medical Devices   East Hanover, NJ   eMarketing / Relationship Marketing Consultant

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Date Posted: 11/22/2009 Last Updated: 11/22/2009

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