Group Director, Regulatory Affairs 1275

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.