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Regulatory Affairs Manager.

Company: Johnson & Johnson
Location: Raynham
Posted on: January 17, 2022

Job Description:

DePuy Synthes Companies of Johnson & Johnson is recruiting for a Regulatory Affairs Manager - Spine, located in Raynham, MA.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.\

Key Responsibilities

  • Direct and coordinate activities concerned with the submission and approval of products to government regulatory agencies.
  • Provide guidance to project team members regarding regulatory compliance issues.
  • Oversee the preparation and maintenance of regulatory submissions and files.
  • Establish accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
  • Ensure adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.
  • 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.
  • Work 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.
  • Ensure organizational compliance with all applicable regulations and J&J policies.
  • Assign projects or activities, provide day-to-day instructions, and suggested training activities to direct reports (if any).

    Education

    Qualifications
    • Bachelor's Degree in a scientific, engineering, business, or legal disciple is required
    • At least 8 years of relevant or regulated industry experience
    • Familiarity with US and European medical device regulatory processes
    • Demonstrated track record of developing and executing global regulatory strategies that align with business results
    • Leadership experience

      Preferred Skills & Experience
      • Previous experience with medical devices
      • Experience working with professional and trade associations
      • Experience in preparing and submitting US regulatory files (510(k)s, PMAs) as well as European Technical Files and Design Dossiers
      • Must have excellent written, verbal communication and presentation skills.

        Other
        • This position is located in Raynham, MA may require up to 10% domestic/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-Massachusetts-Raynham-325 Paramount Drive

          Organization

          Medical Device Business Services, Inc (6029)

          Job Function

          Regulatory Affairs

          Requisition ID

          2105974063W

Keywords: Johnson & Johnson, Brockton , Regulatory Affairs Manager., Executive , Raynham, Massachusetts

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