Requisition ID: 1805661454W
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials.
Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
The Regulatory Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy Synthes line of products. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k) and PMA) or internal regulatory assessment documentation. The regulatory specialist is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of Synthes products for compliance to FDA regulations and company policies and procedures.
· Represent regulatory affairs on product development teams by attending team meetings and providing the global regulatory plan, regulatory assessments and regulatory decisions
· Prepare regulatory documentation for Synthes devices, including IDE, 510(k) and PMA documentation for submission to the Food and Drug Administration (FDA). This includes the resolution of regulatory issues and questions from regulatory agencies during the premarket product development phase
· Assist in the preparation of approval documents to support rest of world registrations.
· Additional activities may require notarization and legalization of documents, and requesting of Certificates to Foreign Government and Free Sale Certificates
· Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant US regulations and guidance
· Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant US regulations and guidance
· Assist with the maintenance of the regulatory database with accurate and current regulatory information
· Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards, ISO 9001/13485, MDD, CMDCAS/CMDR, etc.)
· Attend conferences, seminars, professional meetings, and other public forums that are relevant to the regulatory interests of Synthes
· Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
· Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer