J&J Family of Companies Manager, Regulatory Affairs, China Support in Warsaw, Indiana
DePuy Synthes, a member of Johnson & Johnson family of companies, is currently recruiting for a Manager, Regulatory Affairs, China Support. The U.S. based Regulatory group is in Warsaw, IN however consideration can be given to working remote within the United States 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.
Responsible for interfacing between the DePuy Synthes New Product Development, Research and Regulatory Affairs department and JJMC Regulatory Affairs to develop the technical documentation necessary to obtain approval for DePuy products in China. Responsibilities include Joint Reconstruction and Power Tools. May also prepare or support preparation of a significant portions of Chinese registration dossiers as required. May interface with International Regulatory Agencies and Health Authorities (CFDA) to obtain products approvals as required. May also work with J&J Suzhou Product Development and Regulatory Affairs.
POSITION DUTIES & RESPONSIBILITIES:
Analyze Chinese medical device standards and guidances and work with NPD and Research, DePuy Regulatory Affairs and JJMC Regulatory Affairs to ensure that documentation and device specifications for the Testing Center are accurate.
Coordinate responses to any questions raised by the Testing Center during the testing process.
Review technical documentation for submission to the CFDA Center for Medical Device Evaluation (CMDE). Coordinate gathering of any additional documentation and technical information necessary for effective submissions to CMDE.
Coordinate responses to any SFDA CMDE technical questions.
Integrate Chinese regulatory requirements into DePuy Synthes new product development process.
Participate in Lean and other process improvement efforts and implement improvements.
Work with J&J Suzhou Development and Regulatory Affairs departments as required.
Functional and Technical Competencies:
Works with team members and commercial partners to oversee the regulatory aspects of new products launches, the submission of license applications, and the assessment of the impact product changes have on the status of regulatory licenses.
Interprets regulatory requirements and determines strategies to obtain clearances and approvals
Independently makes decisions regarding work processes or operational plans and schedules
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
Connect by cultivating external relationships with regulators in China and internally collaborating with the R&D, Med Affairs, Clinical Affairs, GSM and other partners.
Shape by executing strategies developed by the Regulatory Policy Team and China Strategy Leader.
Lead by supporting regulatory professionals and transparently communicating in a constructive manner
Deliver by mobilizing and inspiring an accountable team to deliver results for on-time clearances and approvals with a global and enterprise-wide mind-set and balance with strategic and short-term goals
Minimum of a B.A. /B.S. within a technical related discipline is required a Master’s Degree is preferred.
Minimum 8 years relevant / regulated industry experience is required.
Previous experience with medical devices is strongly preferred.
Chinese language skills reading and writing (Manadarin) is required.
Knowledge of US, EU and China Medical Device Regulations preferred.
Experience working with professional and trade associations is a plus.
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)