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Project Lead, Regulatory Affairs
Requisition ID: 4360180226
Mitek Sports Medicine, part of the DePuy Synthes Companies of Johnson & Johnson is recruiting for a Project Lead, Regulatory Affairs - Mitek Sports Medicine located in Raynham, MA.
DePuy Synthes Mitek is the Sports Medicine business offering orthopaedic sports medicine products, soft tissue repair devices, joint movement solutions and minimally invasive and arthroscopic solutions.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will 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, we have created one organization with a focus on activating insights to develop innovative, comprehensive healthcare solutions.
- Lead and manage submission activities for US, EU and support worldwide
- Support Center of Excellence projects.
- Interacts with regulatory agencies in submission activity, regulations and policy, and franchise initiatives.
- Complete company and departmental reports to outline / summarize regulatory actions.
- Provide regulatory strategies and support projects in the innovation platform.
- Provide leadership, personal development, training, coaching and mentoring for staff.
- Work with team members and commercial partners to support regulatory aspect of NPD, base business, innovation, license applications and renewals.
- Interpret regulatory requirements and determine strategies to obtain clearances and approvals.
- Ensures organizational compliance with all applicable regulations and JNJ policies.
- Strong understanding of US, EU and international regulations.
- Experience in Medical devices with software, regulated by electrical STeDs and or electromechanical devices (visualization).
- Connect to cultivate external relationships with affiliates, and internal cross functional partners.
- Shape by executing strategies developed by COE for both Regulatory + Digital Platform.
- Lead team by example and mentoring
- Deliver results for timely submissions regulatory documentation with global strategy balance.
- Bachelor’s degree within a technical related discipline and 6+ years’ experience or Master’s degree with equivalent experience. (preference in medical devices)
- Demonstrated track record of developing executable global strategies and align with business deliverables.
- Prior interaction with the FDA and Notified Bodies is required and other worldwide agencies preferred.
- The candidate must have a demonstrated experience for preparing and submitting 510(k)’s in addition to preparation of EU Design Dossiers/Technical Files.
- Previous experience working with cross functional teams within a matrix environment is required.
- Experience with worldwide regulatory registrations is required.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Depuy Orthopaedics. Inc. (6029)