DePuy Synthes, Inc. is currently recruiting for a Regulatory Affairs Manager for a 2 year contractual position 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 Manager will lead and/or execute regulatory activities to support currently-marketed or new medical 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:
- Oversee all regulatory aspects of the MDR program.
- Define and manage key project constraints such as scope, schedule and risks.
- Support audit strategies as well as the implementation of MDR compliant QMS procedures.
- Support communication strategy to NPD staff to maximize understanding of expected impact from the MDR program to NPI.
- Collaborate with stakeholders to develop and maintain project plans.
- Create, monitor and analyze project risks and identify mitigation strategies.
- Be responsible for all project communications to all cross-functional project stakeholders and communications include: project websites, meeting minutes, status reports, presentations, and any other detailed project information needed.
- Report metrics of completion status to manager / Leadership Team.
- Work with project team to identify and address critical path or road block issues.
- Ensure project plans and deliverables are compliant with appropriate design control procedures and any other applicable procedures and/or regulations.
- Be the liaison with stakeholder managers as needed to ensure project goals are achieved.
- Know and follow all laws and policies that apply to the job and maintain the highest levels of professionalism, ethics and compliance at all times.
- To ensure timely execution of project objectives, the candidate must have strong problem-solving skills and initiative, and the ability to provide efficient escalation of issues to the appropriate accountable part.
- Review and approval of documentation to support Technical Document to meet MDR requirements.
- Participate in cross functional teams to discuss and revise documents to meet MDR requirements.
- A minimum BA/BS Degree with at least 8 years of regulated medical device industry experience (or related) OR a Masters degree or higher with at least 6 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
- 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 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.
Medical Device Business Services, Inc (6029)