J&J Family of Companies Regulatory Affairs Manager in Raynham, Massachusetts
DePuy Synthes is recruiting for a Regulatory Affairs Manager, 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 (http://www.depuysynthes.com./)
The Regulatory Affairs Manager is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy Joint Reconstruction portfolio. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Design Dossiers, and Technical Documentation) or internal regulatory assessment documentation. The Regulatory Project Leader is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of DePuy Synthes products for compliance to global regulations and company policies and procedures. In conjunction with other functions they support post market and provide lead external and Internal audits.Duties:
Prepares 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 the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase.
Provides support in preparation, writing and submission 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.
Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
Review and approve changes with Product Lifecycle Management System to devices, design, packaging and labelling for Notified Body, FDA, and Global impact
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 regulations and guidance.
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.).
FDA compliance for Joint Reconstruction – Annual Reports, Reporting on Supplements & Submissions, and FDA compliance project activities.
Special Compliance Projects
MDR Sustainability and compliance
Delegating responsibilities and supervising business operations
Hiring, training, motivating and coaching employees as they provide attentive, efficient service to customers, assessing employee performance and providing helpful feedback and training opportunities.
Resolving conflicts or complaints from customers and employees.
To carry out such further tasks that may be delegated to me by my immediate manager.
Professional experience requirements:
A minimum of a Bachelor and at least 4 years of relevant regulatory affairs is required.
A minimum of 6 years plus medical device industry experience or relevant medical device experience is required
1 year of management experience preferred
Knowledge 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 is preferred.
Familiarity with electronic submission preparation a plus.
Excellent written and oral communication skills is required.
Ability to handle multiple tasks, self-motivate and be detail oriented is required.
This position is to be located in the US and will require up to 15% travel (after COVID allows) domestic/internationally.
BA/BS Degree required; advanced 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.
North America-United States-Massachusetts-Raynham, North America-United States-District of Columbia-Washington, North America-United States-Florida-Palm Beach Gardens, North America-United States-Indiana-Warsaw
Medical Device Business Services, Inc (6029)
J&J Family of Companies
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