Senior Regulatory Affairs Associate - (Job Number: 0805374)

Senior Regulatory Affairs Associate - (Job Number: 0805374) DescriptionCodman & Shurtleff, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Regulatory Affairs Associate located in Raynham, MA. DePuy, Inc. develops and markets products under the DePuy Orthopaedics, DePuy Spine, CODMAN and MITEK brands. DePuy Orthopaedics and DePuy Trauma and Extremities provide products for reconstructing damaged or diseased joints, and for repairing and reconstructing traumatic skeletal injuries. DePuy Spine facilitates fusion of the spine and correction of spinal deformities, including CHARIT, the first artificial spinal disc. Codman provides for the surgical treatment of neurological and central nervous system disorders through products such as hydrocephalic shunt valve systems, implantable drug pumps and micro-surgical instrumentation. DePuy Mitek offers innovative devices in sports medicine for the treatment of soft tissue injuries. The Senior Regulatory Affairs Associate will prepare US and International regulatory submissions, including, but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, Annual Reports, IND/NDA Supplements, Design Dossiers/Change Notifications, and Technical Files. They will work with management to devise strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products. This position will participate and provide guidance and support to product development teams on both US and international issues. The ideal candidate will review and analyze labeling, manufacturing, marketing and clinical protocol procedures and documents. They will also review and provide regulatory authorization for Engineering Change Orders (ECOs). In addition this position will review and analyze technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance or other related departments, review, archive and analyze relevant literature, and respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates. A minimum of a Bachelor's Degree is required. Advanced degree is preferred. Must have a minimum of 6 years experience working in a Regulatory Affairs role. Preparing submissions for complex Class II or Class III medical devices is a plus. Experience with NDA, IND submission is a plus. Experience in the independent preparation and submission of 510(k)'s, PMA Supplements or IDEs is desired. Experience in FCC/RF exposure issues, IEC electrical safety and EMC testing requirements, and software validation of implantable medical devices is preferred. Previous experience in pharmaceutical regulations is preferred. Solid Knowledge of US and European regulatory processes is required. Must have excellent written, verbal communication and presentation skills, including experience presenting at FDA meetings. Must be able to communicate clearly, succinctly and effectively over the phone and in writing. Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive. Must be able to work in a timeline 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