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Regulatory Affairs Project Manager - LCM

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Job Description


DePuy Synthes, Inc. is currently recruiting for a Regulatory Affairs Life Cycle Management Project Manager, located in Raynham, MA.


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 Manager will lead and/or execute regulatory activities to support currently-marketed devices in the DePuy Synthes sports medicine line of products. This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects & activities that directly impact the operational results of the business.


In this role, you will:

  • Effectively manage project priorities across multiple platforms and drive decisions to ensure life cycle management success.
  • Define regulatory requirements on a project by project basis to achieve compliance.
  • Define resource requirements based on regulatory requirements on a project by project basis.
  • Communicate effectively with Management. Report periodic status updates, completion of major milestones and roadblocks.
  • Work with project team to identify and address critical path or road block issues.
  • Create robust global regulatory strategies.  Ensure changes are effectively communicated to global partners for registration impact.
  • Ensure project plans and deliverables are compliant with appropriate design control procedures and other global regulation requirements as applicable.
  • Compiles regulatory submissions, filing amendments and correspondence with US and EU regulatory authorities.
  • Support International team with product re-registration.
  • Mentor junior team members.
  • Participates in process improvement and corporate initiatives as appropriate.
  • Support various audits as related to LCM projects.
  • Maintains knowledge of current applicable regulations and guidance documents.
  • Maintains the highest levels of professionalism, ethics and compliance at all times.


Qualifications
  • A minimum BA/BS Degree with at least 6 years of regulated medical device industry experience (or related) OR a Masters degree or higher with at least 4 years of regulated medical device industry experience (or related) 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
  • Strong problem-solving skills and the ability to provide efficient escalation of issues to the appropriate accountable part is required
  • Familiarity with electronic submission preparation a plus
  • Excellent written and oral communication skills is required
  • Ability to handle multiple tasks and be detail oriented is required
  • This position is located in Raynham, MA 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.



Primary Location
United States-Massachusetts-Raynham-
Organization
Medical Device Business Services, Inc (6029)
Job Function
Regulatory Affairs
Requisition ID
5273200115