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Manager, Regulatory Affairs

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Job Description


Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Manager, Regulatory Affairs, to be located in Cincinnati, Ohio.


The Ethicon business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today. Ethicon, with their deep expertise in minimally invasive surgery and advanced instrumentation, is developing surgical instruments for Verb Surgical's new robotics-assisted platform.


The Manager, Regulatory Affairs will provide support to the Regulatory Affairs, and have the opportunity to be part of a team responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance. You will create regulatory strategies and translate into executable plans for the Energy Team, and the scope may evolve into other product franchises over time. The position generally has responsibility for projects of medium and large scope, such as accountability for regional/multi-functional registrations and submissions.

In this role, you will:
  • Prepare and maintain regulatory submissions and files.
  • Provide guidance to project team members regarding regulatory issues.
  • Interact with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.
  • Consult with management personnel to establish and prepare appropriate regulatory filings for product approvals.
  • Shape by creating and executing Regulatory strategies.
  • Direct author and/or support of recent US Regulatory Submissions
  • Have knowledge of EU submissions including familiarity with MDD/MDR
  • Have the ability to partner, influence and build positive healthy relationships with key stakeholders on NPD and Lifecycle teams.
  • Leverage scientific and technical understanding of medical devices to serve as an expert resource and strategic partner for development and planning throughout the product lifecycle in applicable markets.
  • Build, sustain, and reward a culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments.
  • Connect by cultivating external relationships and internally collaborating with the R&D, Medical Affairs, Clinical Affairs, GSM and other partners.
  • Deliver by mobilizing and inspiring an accountable team to deliver results for on-time clearances with a global and enterprise-wide mind-set and balance with strategic and short-term goals.


Qualifications
  • Minimum of a B.A. /B.S. is required.  An advanced degree is a plus.
  • Minimum of 8 years of professional experience is required.
  • Minimum of 6 years of direct regulatory experience is required.
  • Direct author and/or support of recent US Regulatory Submissions is required.
  • Knowledge of EU submissions including familiarity with MDD/MDR is required.
  • Previous functional experience that is technically or scientifically related (i.e. quality, medical, clinical and R&D) is preferred.
  • Demonstrated track record of developing and executing global strategies that align with business deliverables is preferred.
  • Knowledge of International Regulations in China, Japan, Brazil and Russia helpful.
  • RAC is preferred.
  • Excellent written, verbal communication and presentation skills
  • Ability to partner and influence key stakeholders on NPD and Lifecycle teams is required.
  • Leverages scientific and technical understanding of medical devices to serve as a resource and strategic partner for development and planning throughout the product lifecycle in applicable markets is required.
  • Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives is required.            
  • Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions is required.
  • This position is located in Cincinnati, OH and may require up to 10 % domestic and/or international travel

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
United States-Ohio-Cincinnati-
Organization
Ethicon Endo Surgery Inc (6041)
Job Function
Regulatory Affairs
Requisition ID
7955191018