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Associate Director, Regulatory Affairs
Requisition ID: 7582180123
Mitek Sports Medicine, part of the DePuy Synthes Companies of Johnson & Johnson is recruiting for an Associate Director, 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.
Administer the day-to-day Regulatory Affairs operations by directly or indirectly managing teams of employees or managing third-party vendors. In addition, these jobs exhibit a high degree of independent judgment and execute on plans that directly impact the operational results of business units.
POSITION DUTIES & RESPONSIBILITIES:
- Lead and manage submission activities for US and EU
- Support worldwide registration and collaborate country specific strategies.
- 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 AE platform.
- Provide leadership, personal development, training, coaching and mentoring for staff.
- Independently makes decisions regarding work processes or operational plans and schedules.
- Experience in directly managing multi-level staff, provide direction to work groups and cross functional teams.
FUNCTIONAL / TECHNICAL COMPETENCIES:
- Work with team members and commercial partners to oversee 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 is preferred.
- Connect to cultivate external relationships with affiliates, and interval cross function partners.
- Shape by executing strategies developed by COE.
- Lead team by example and mentoring
- Deliver results for timely submissions regulatory documentation with global strategy balance.
- Minimum of a B.A. /B.S. within a technical related discipline is required. M.S., M.E., PhD or MD is a plus.
- Minimum 8 years relevant / regulated industry experience is required. Previous experience with US and EU medical devices regulation is strongly preferred.
- Demonstrated track record of developing and strategies that align with business deliverables is preferred.
- Leadership experience is required.
- Experience working with professional and trade associations is a plus.
- Knowledge of electrical device and visualization industry standards preferred
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)