Senior Regulatory Affairs Associate (1 of 3) - (Job Number: 0805707)

Senior Regulatory Affairs Associate (1 of 3) - (Job Number: 0805707) DescriptionEthicon Endo- Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Regulatory Affairs Specialist, located in Cincinnati, OH. Ethicon Endo-Surgery, Inc.- develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure- enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastro- intestinal health, gynecology and surgical oncology. Make the immediate jump into innovative PMA regulatory projects. Ethicon Endo-Surgery has filed two ground breaking PMA's in the last year, and more are in progress. An Ethicon Regulatory Affairs Associate II will assist with activities necessary for the timely preparation, writing & submitting of international registrations (technical files), 510(k)s (Pre-market Notification), IDEs (Investigational Device Exemptions), PMAs (Pre Market Approvals), PDPs (Product Development Protocols), all related amendments and supplements. The ideal candidate will analyze and critically appraise work-products (usually technical reports or published journal articles) from the technical community and apply these to regulatory processes as necessary without compromising work-product or regulatory integrity. Assist in training, development and supervision of junior regulatory affairs personnel. Communicate with department members, other EES personnel, government agencies and a host of individuals outside the company in a professional, decisive, and articulate manner The Senior Regulatory Affairs Associate will Conduct regulatory activities necessary for the timely preparation, writing & filing of 510(k)s, IDEs (Investigational Device Exemptions), PMAs (Pre Market Approvals), Clinical Trial Dossiers (CTD), & all related amendments & supplements, & global registrations. They will coordinate activities necessary to assure that product labels and labeling comply with US and foreign government regulations. This position will prepare and submit documents necessary to gain US and foreign regulatory approval / clearance for device use during clinical trials. They will also prepare and lead training for junior regulatory personnel. This position will make recommendations and provide guidance to marketing, product development, package engineering and regulatory personnel regarding label content. Review and approve immediate carton labels. Manage the regulatory aspects of new product development for designated products with minimal direction from management. Participate in activities necessary to assure that product labels and labeling comply with US and foreign government regulations. Prepare and submit documents necessary to gain US and foreign regulatory approval / clearance to place new or modified products into commercial distribution. In addition, this position will provide regulatory expertise, make recommendations and give regulatory direction as an integral member of product development teams. The Senior Regulatory Affairs Associate will assist regulatory managers with a specific product development franchise as assigned. The candidate will stay continually aware of new product development activities by being involved in product development teams through ongoing communication with marketing, and research and development departments. A Bachelors degree in science, biomedical engineering, medical / scientific writing, public health administration or related area is required. An Advanced degree in a technical, medical, or business area is preferred. A minimum of 6 years of successful experience conducting regulatory activities that achieved domestic and/or foreign regulatory approval is required. Experience with Class II devices and 510(k) submissions is required. Previous experience with PMA's, PMA Supplements and/or Annual reports is a plus. Experience in clinical trials is a plus. RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society is desired. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now