Johnson & Johnson Careers
Manager, Regulatory Affairs
Requisition ID: 4569180619
DePuy Synthes, a member of Johnson & Johnson family of companies, is currently recruiting for a Manager, Regulatory Affairs. The U.S. based Regulatory group is in Warsaw, IN however consideration can be given to working remote with up to 30% travel.
DePuy Synthes Joint Reconstruction is the Joint Reconstruction business offering orthopaedic devices, solutions and supplies for hip, knee and extremity reconstruction, in addition to cement and operating room products.
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.
The Manager, Regulatory Affairs administer the day-to-day Regulatory Affairs operations by directly or indirectly managing teams of employees or managing third-party suppliers to transfer and maintain medical device manufacturing in Suzhou. This includes US PMA products. In addition, these jobs exhibit a high degree of independent judgment and execute on plans that directly impact the operational results of business units.
- Lead and manage activities concerned with the submission and approval of products and product transfers to government regulatory agencies including US and EU regulatory agencies. Assist in the registration of products and product transfers to Wave 2 Countries.
- Oversees the preparation and maintenance of regulatory submissions and files for Wave 1 (US and EU) countries including US PMA submissions. Oversees process of obtaining data needed for Wave 2 Countries for China specific transfers.
- Interacts with regulatory agency personnel to expedite approval of pending application and to resolve regulatory matters.
- Provides leadership, personnel development, training, coaching, and mentoring for staff especially regarding US and EU regulations.
- Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.
- Works with team members and partners to oversee the regulatory aspects of product transfers, the submission of license applications, and the assessment of the impact product changes have on the status of regulatory licenses for Wave 1 (US and EU) and Wave 2 Countries.
- Interprets regulatory requirements and determines strategies to obtain approvals for transfers and new product launches for products manufactured in China.
- Makes decisions regarding work processes or operational plans and schedules in concert with Business Wave 1 and Wave 2 Regulatory personnel.
- Ensures organization compliance with all applicable regulations and J&J policies
- Provides day-to-day instructions and suggested training activities to direct reports (if any)
- Assigns projects or activities to individual contributors
- Manages and provides direction to a work group
- Expert in US, EU and International Regulations
- A Bachelor’s Degree within a technical related discipline is required a Master’s Degree is preferred.
- A minimum 8 years relevant/regulated industry experience is required.
- Previous US Premarket Approval (PMA) experience is required.
- Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required.
- Ability to lead and influence others above direct authority is required
- Experience working with professional and trade associations is a plus.
- Knowledge of International Regulations in China is 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.
North America-United States
Depuy Orthopaedics. Inc. (6029)