Johnson & Johnson Careers
Senior Regulatory Affairs Specialist
Requisition ID: 4585190117
DePuy Synthes, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Senior Regulatory Affairs Specialist for the Joint Reconstruction team, located in Warsaw, IN.
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. For more information, visit www.depuysynthes.com
This Senior Regulatory Affairs Specialist will administer the day-to-day Regulatory Affairs operations as directed by the Associate Director related to product Lifecycle Management (LCM), Supply Chain and Change Management in the US and EU markets. This includes US PMA products. In addition, these jobs exhibit a 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.
- Prepare, draft and file regulatory submissions to support product approvals for US and EU countries including US PMA products.
- Develop pragmatic strategies and implementation plans, establishes accountability for the preparation of regulatory submissions.
- Assist in the registration of products and product transfers internationally.
- Interact with regulatory agency personnel to expedite approval of pending application and to resolve regulatory matters.
- Work independently to oversee multiple projects simultaneously and be responsible for contributing to and independently developing business strategies and project timelines.
- Represent Regulatory Affairs on cross-functional project teams, and provide independent regulatory guidance to teams in strategic planning, product lifecycle, transfers, and the assessment of the impact product changes have on the status of regulatory licenses US and EU markets.
- Plan schedules for regulatory deliverables on projects and monitors projects through completion. This may include management of Contractor resources.
- Establish accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides to communicate status
- Provide Regulatory Affairs support during internal and external audits.
- Ensure adherence to standard operating procedures and protocol for the rapid and timely approval of regulatory support of marketed products.
- Ensure organization compliance with all applicable regulations and J&J policies
- Assist in the development of best practices for Regulatory Affairs processes.
- Connect by cultivating external relationships with regulators in US and EU (in partnership with Regions, Policy and EU Strategy leads) and internally collaborating with the R&D, Med Affairs, Clinical Affairs, GSC and other partners.
- Deliver results for on-time clearances and approvals with a global and enterprise-wide mind-set and balance with strategic and short-term goals
- Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels and by acting with speed, flexibility, accountability, and appropriately managing priorities to deliver results for on-time clearances
- Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with regulatory agencies, industry groups, standards committees, political/government agencies, to influence external stakeholders and promote Regulatory perspectives
- A minimum of a BA/BS within a technical related discipline is required
- A minimum of five (5) years of relevant/regulated industry experience is required.
- The ability to manage multiple priorities and work independently is required.
- Previous experience with US and EU medical device regulations is required.
- Experience with the preparation, submissions and approval for Class II and III medical devices is required.
- Strong problem-solving skills and the ability to design, structure, and lead projects are preferred.
- The ability to build and maintain credibility with senior leaders is preferred.
- Demonstrated ability to collaborate across functional and geographic boundaries is preferred.
- Experience developing and executing global regulatory strategies that align with business deliverables is preferred.
- Experience working with professional and trade associations is a plus.
- This position will be located in Warsaw, IN and may require up to 10% domestic/international travel.
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)