Johnson & Johnson Careers
Regulatory Affairs Project Leader - LCM
Requisition ID: 9424190729
DePuy Synthes, Inc. is currently recruiting for a Regulatory Affairs Project Leader – LCM, located in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson offer an unparalleled breadth and depth of orthopedic products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, craniomaxillofacial (CMF), power tools, and biomaterials. DePuy Synthes is agile and focused to meet the needs of today’s evolving health care environment, inspired to advance patient care through developing innovative and comprehensive solutions.
The Regulatory Affairs Project Leader – LCM will lead and/or execute regulatory activities to support currently-marketed or new medical devices in the DePuy Synthes Trauma/CMF line of products. This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of Life Cycle Management projects & activities that directly impact the operational results of the business.
In this role, you will:
- Directly contribute to governance of LCM projects by participating in cross-functional Product Focus Teams to assess & prioritize changes.
- For proposed change projects, assess the need for technical & regulatory documentation updates, global regulatory actions (notifications/re-registrations), and resources/effort required.
- Monitor & evaluate ongoing projects and supporting regulatory resources, as well as assign new projects/activities to other Regulatory Affairs personnel within the LCM ticketing system.
- Provide regulatory guidance to LCM and new product development teams and respond to product information requests.
- As needed for assigned projects, author and support the preparation of regulatory documentation, including IDE, 510(k), PMA, Technical File and Design Dossier documentation for submission to regional Health authorities. Support includes the resolution of regulatory issues and questions from regulatory agencies during any pre or post-market product development phase.
- 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 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 regulations and guidance.
- Assist with the maintenance of the regulatory databases with accurate and current regulatory information.
- Assist in the development of best practices for Regulatory Affairs processes
- Provide Regulatory Affairs support during internal and external audits
- Perform other duties as assigned.
- A minimum BA/BS Degree required; Masters or equivalent preferred
- Minimum 6 years of regulated medical device industry experience is required; knowledge of orthopedic implants a plus
- Knowledge of U.S. FDA and EU MDD & MDR medical device regulations and guidances is required
- Demonstrated experience with planning, oversight, and execution of multiple projects is required; project management training & certification is a plus
- Familiarity with international regulations and guidance (such as China, Brazil, Japan, etc.) a plus
- Familiarity with electronic submission preparation a plus
- Excellent written and oral communication skills
- Ability to handle multiple tasks and be detail oriented
- This position is located in West Chester, PA and may require up to 10% travel, domestic and/or international.
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.
United States-Pennsylvania-West Chester-
Medical Device Business Services, Inc (6029)