Johnson & Johnson Careers
Regulatory Affairs Manager
Requisition ID: 2447180528
DePuy Synthes Companies of Johnson & Johnson is recruiting for an Regulatory Affairs Manager, located in Palm Beach Gardens, FL.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic 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.
- Management of Regulatory activities associated with Synthes Power Tools Division, both pre- and post-market.
- Interface with Product Development groups to discuss US, Canada, EU, and global regulatory requirements and pathways to market.
- Develop regulatory strategies for new/modified products.
- Provide leadership and support to Power Tools Regulatory Affairs group.
- Direct the preparation of regulatory submissions for various regulatory agencies e.g. US FDA, Health Canada, Notified Body, etc.
- Prepare and submit US FDA and Health Canada regulatory documentation, including original submissions and any subsequent correspondence.
- Engage regulators, when necessary, in oral communications to discuss pending or new submissions, regulatory requirements, etc.
- Develop and propose regulatory pre-market strategies in cooperation with other departments, and other Synthes locations as dictated
- Work cooperatively with Product Development groups to achieve compliance with regulatory requirements.
- Develop and administer regulatory education programs
- Provide regulatory consultation to senior management regarding regulatory issues related to new products
- Departmental duties similar to that of Senior RA Specialist.
- Provide support and assistance as required to the Vice President, Regulatory & Clinical Affairs
- Responsible for mentoring and developing the professional skills of Regulatory Affairs employees
- Assess resource needs and allocate departmental resources to assure accomplishment of corporate goals for new product approvals.
- Foster credibility of the Regulatory Affairs group with stakeholders such as FDA, Product Development, Manufacturing, etc.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities.
- Consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance to the Chief Compliance Officer.
- Other duties as assigned
- BA/BS Degree from an accredited four year college or university
- Advanced degree preferred
- Regulatory Affairs Certification (RAC) preferred, not required
- A minimum of 10 years of prior experience in regulatory submissions
- A minimum of 5 years of management experience in medical device Regulatory Affairs
- A minimum of 5 years of experience in the Medical Device Industry
- Specific experience with US Class II medical devices
- Expert understanding of medical device regulations
- Knowledge of statistical concepts as they apply to Regulatory Affairs
- Expert understanding of Regulatory Affairs methodology, including GMPs
United States-Florida-Palm Beach Gardens
Depuy Orthopaedics. Inc. (6029)