Regulatory Changes PMO Lead

Johnson and Johnson

DePuy Synthes, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Regulatory Changes Program Lead to be located in the US (Raynham, MA; Warsaw, IN; West Chester, PA; or Washington, D.C.); Ireland (Cork); England (Leeds); or remote (globally) for the right candidate.

DePuy Synthes, the Orthopaedics Company of Johnson & Johnson, provides one of the most comprehensive orthopaedics portfolios in the world that helps heal and restore movement for the millions of patients we serve. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, in addition to the VELYS™ Digital Surgery portfolio, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide.

Building on our proud product innovation and legacy of industry firsts, we are reimagining the orthopaedic landscape with new advancements in medical technologies and digital surgery across the entire continuum of care to Keep People Moving today and tomorrow.

The Regulatory Changes Program Lead is responsible for the regulatory management and delivery of franchise-specific outputs for sector-wide regulatory projects, such as the EU MDR program, into the global market (for OEU MDR, this is excluding CE mark and US). This role requires the development of a comprehensive RA strategy and execution of the strategy in all additional markets in which product is offered. 

In this role, you will:

  • Develop, maintain, and execute comprehensive RA strategies for Global regulated markets for major regulatory change projects, such as OEU MDR.
  • Manage operational teams by establishing and maintaining essential processes, keeping products compliant with local country requirements and ensuring minimal impact on Supply Chain effectiveness and product disruptions.
  • Create, maintain, and communicate appropriate program documentation to meet business goals and program objectives.
  • Work with the franchise representatives to identify and adapt where applicable, Global Supply Chain processes within the franchise that are impacted by the regulatory legislation and recommend solutions required to achieve compliance. 
  • Focus on IT Systems (MDRIM) coordination and close liaison with resource to ensure timely solutions to registrations.
  • Identify business process owners and align and implement process changes, identify risks and issues and escalates as necessary.
  • Identify and work with the Supply Chain Franchise Leads to resolve technical, operational, and organizational challenges related to regulation change. 

Qualifications

  • A minimum of a Bachelor’s degree with at least 8 years working in the medical device, pharmaceutical or regulated industry is required.
  • At least 5 years of experience working in a complex matrix environment is required.
  • People management experience is preferred.
  • At least 3 years working in Regulatory Affairs or related area is preferred
  • Working knowledge of regulatory requirements, processes, and terminology is required.
  • Experience in working at the interface between systems, processes, and business is preferred.
  • Demonstrated written and verbal communications skills in English, able to quickly build credibility within Franchises and Regions is required. 
  • Demonstrated project management skills with strong ability to influence in a highly matrixed environment as required.
  • Ability to influence people and decision making to ensure the franchise and workstream leads are fully informed around the current status of global implementation plan is required.
  • Ability and confidence to effect informed decisions based on regulatory trends, government constraints and an understanding of business needs is required.
  • This position is to be located in the US (Raynham, MA; Warsaw, IN; West Chester, PA; or Washington, D.C.); Ireland (Cork); England (Leeds); or remote (globally) for the right candidate and will require up to 20% travel (after COVID allows) domestic/internationally.

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. 

Primary Location

United States-Massachusetts-Raynham-325 Paramount Drive

Other Locations

Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw, North America-United States-Pennsylvania-West Chester, North America-United States-District of Columbia-Washington, Europe/Middle East/Africa-Ireland-Cork-Cork, North America, Asia Pacific, Latin America, Europe/Middle East/Africa, North America-United States, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Ireland, Europe/Middle East/Africa-United Kingdom-England-Leeds

Organization

Medical Device Business Services, Inc (6029)

Job Function

Regulatory Affairs

Requisition ID

2105928292W

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Confirmed a day ago. Posted 30+ days ago.

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