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Regulatory Change PMO Leader

Company: J&J Family of Companies
Location: Annapolis
Posted on: November 26, 2022

Job Description:

Regulatory Change PMO Leader - 2206087761WDescriptionJohnson & Johnson Medical Devices including both Global Surgery and Cardiovascular Specialty Solutions, is currently recruiting for an OEU MDR Regulatory Lead, located in any Johnson & Johnson US Medical Device Location or remote.This role is a duration-based role of at least one year with the full duration to be determined in conjunction with the MDR program.The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.The OEU MDR Regulatory Lead is responsible for the regulatory management and delivery of the franchise specific EU MDR program into the global market (excluding CE mark and US). This role requires the development of a comprehensive RA strategy and execution of the strategy in the additional 112 markets in which product is offered. This role is a duration-based role of at least one year with the full duration to be determined in conjunction with the MDR programKey Duties:

  • Develops, maintains and executes comprehensive RA strategies for Global regulated markets
  • Manages 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
  • Creates, maintains and communicates appropriate program documentation to meet business goals and program objectives
  • Work with the MDR Franchise Leads to identify and adapt where applicable, Global Supply Chain processes within the franchise that are impacted by the EU MDR legislation and recommend solutions required to achieve MDR compliance
  • Focus on IT Systems (MDRIM) coordination and close liaison with resource to ensure timely solutions to registrations
  • Identify business process owners and works with them to agree 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 MDR
  • Other related duties maybe assignedQualifications
    • Bachelors degree is required, in a technical related discipline is preferred
    • 10 years working in the medical device, pharmaceutical or regulated industry is required
    • 3 years experience working in a complex matrix environment is preferred; people management preferred
    • 3 years working in Regulatory Affairs is required
    • Working knowledge of regulatory requirements, processes and terminology is required
    • Must possess relevant business knowledge in addition to a strong record of delivery, problem solving, working across global teams, process development and project planning, scheduling and leadership skills is highly preferred
    • Experience in working at the interface between systems, processes and business is required
    • Demonstrated written and verbal communications skills, able to quickly build credibility within Franchises and Regions is required
    • Demonstrated project management skills are required, a PMP is a plus
    • Ability to work collaboratively in a matrixed environment, building partnerships and teamwork across local and global organizations as required
    • Ability to influence people and decision making to ensure the MDR Franchise and Work steam Lead are fully informed around the current status of global implementation plan is highly preferred
    • Ability and confidence to effect informed decisions based on regulatory trends, government constraints and an understanding of business needs is required
    • Excellent detail orientation and communication skills is required
    • Ability to travel up to 10%, domestic and international, is requiredThe anticipated base pay range for this position is $129.500 to $223,100. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/ performance year. Bonuses are awarded at the Companys discretion on an individual basis.Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please go to: you want to be part of a diverse team delivering innovative products to market? Apply today!At Johnson & Johnson, were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary Location NA-US-Massachusetts-RaynhamOther Locations NA-United StatesOrganization Medical Device Business Services, Inc (6029)Job Function Regulatory AffairsReq ID: 2206087761W

Keywords: J&J Family of Companies, Baltimore , Regulatory Change PMO Leader, Other , Annapolis, Maryland

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