Regulatory Affairs Specialist I

ÞPuy Synthes is recruiting for a Regulatory Affairs Specialist I, located in the United States; Warsaw, IN; Raynham, MA; Palm Beach Gardens, FL; Washington, DC. DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. We offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two phenomenal companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop creative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own. For more information, visit www.depuysynthes.com Overall responsibilities: The Regulatory Affairs Specialist I is responsible for the preparation for submission of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Technical File, Design Dossiers, and Technical Documentation files) or internal regulatory assessment documentation. Maintains documentation on key market regulatory requirements and the status of product registrations, utilizing internal tracking mechanisms. Duties: Prepare and/or assist in creation of regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical Files, Design Dossier, and Technical Documentation files for submission to regional Health authorities per FDA, MDD and MDR requirements. This includes preparing regulatory documentation for submission, filing and maintenance of those documents. With support from Senior RA personnel provide support in preparation of global registration activities (Japan, China, Australia, NZ) requirements. Incumbent knows, understands, incorporates and follows all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct. Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD, etc.). Perform other duties as assigned. Qualifications Professional experience requirements: Minimum 1- 2 years of prior regulatory affairs or experience in medical devices, preferred Knowledge and/or Familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance’s and standards is preferred Knowledge of orthopedic implants a plus Familiarity with electronic submission preparation a plus Excellent written and oral communication skills are required Ability to handle multiple tasks, self-motivate and be detail oriented is required Educational requirements: BA/BS Degree or equivalent work experience preferred Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-Indiana-Warsaw- Other Locations North America-United States-Massachusetts-Raynham, North America-United States-District of Columbia-Washington, North America-United States-Florida-Palm Beach Gardens Organization Medical Device Business Services, Inc (6029) Job Function Regulatory Affairs Requisition ID 2105993284W