Manager, Regulatory Affairs - (Job Number: 0803719)

Manager, Regulatory Affairs - (Job Number: 0803719) DescriptionCodman & Shurtleff, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Manager, Regulatory Affairs 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 Manager, Regulatory Affairs will coordinate the preparation of US and International regulatory submissions, including, but not limited to 510(k), IDE, PMA Supplements, Design Dossiers/Change Notifications, and Technical Files. The ideal candidate will have the ability to devise strategic regulatory plans to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products. This position is directly responsible for the management and development of up to 5 associates. This position will participate and provide guidance and support to Codman management board and product development teams. Review and analyze ECOs, NCRs, special devices, labeling, manufacturing, marketing and clinical protocol procedures and documents. Review and analyze technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance or other related departments. Review, analyze and incorporate into submissions relevant clinical literature. 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. Interact with Regulatory Agencies and direct/expedite submissions through approval process. A minimum of a Bachelor's Degree is required. An Advanced Degree is preferred. Must have a minimum of 8 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. A minimum of 2 years direct management experience is required. Experience in the independent preparation and submission of 510(k)'s, PMA Supplements or IDEs is desired. Must have proven experience managing complex project teams dealing with day-to-day issues. Experience in drugs/biologics of complex Class III devices is preferred (including devices that incorporate software or electronics) Knowledge of US, European and International regulatory processes is required. Experience conducting due diligence activities from a Regulatory/business standpoint is a plus. Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive is required. Must be able to work in a timeline-driven environment. Solid word processing skills with knowledge of Word, Visio, PowerPoint and Microsoft Project is required. 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