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Regulatory Affairs Manager
Requisition ID: 8050180405
DePuy Synthes Companies of Johnson & Johnson is recruiting for a Manager, Regulatory Affairs, in its Spine division, located in Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies 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 great 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 innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own. To learn more, visit www.depuysynthes.com.
- Direct and coordinate activities concerned with the submission and approval of products to government regulatory agencies.
- Provide guidance to project team members regarding regulatory compliance issues.
- Oversee the preparation and maintenance of regulatory submissions and files.
- Establish accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Ensure adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.
- Interact with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.
- Consult with management personnel to establish and prepare appropriate regulatory filings for product approvals.
- Work with team members and commercial partners to oversee the regulatory aspects of new products launches, the submission of license applications, and the assessment of the impact product changes have on the status of regulatory licenses.
- Ensure organizational compliance with all applicable regulations and J&J policies.
- Assign projects or activities, provide day-to-day instructions, and suggested training activities to direct reports (if any).
- Bachelor’s degree required; education in scientific or engineering discipline preferred; advanced degree preferred.
- Minimum 8 years business experience with 4 years of regulated industry experience is required.
- Previous experience with medical devices is strongly preferred.
- Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required.
- Demonstrated leadership/supervisory experience within a matrix environment is preferred.
- Experience working with professional and trade associations is preferred.
- Familiarity with US and European medical device regulatory processes is required.
- Experience in the preparation and submission of US Regulatory files (510(k)s, PMAs) as well as European Technical Files and Design Dossiers is preferred.
- Must have excellent written, verbal communication and presentation skills.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Depuy Orthopaedics. Inc. (6029)