Manager, Regulatory Affairs

Zuchwil, Canton of Solothurn, ch
Company: Johnson & Johnson
Category: Business and Financial Operations Occupations
Published on 2021-06-21 04:13:57

DePuy Synthes, a Johnson and Johnson company, is recruiting for Manager, Regulatory Affairs within the Power Tools team to be located in Palm Beach Gardens, Florida; Oberdorf, Switzerland; Zuchwil, Switzerland; or remote (in the United States, United Kingdom, or Switzerland) 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, 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 Manager, Regulatory Affairs will administer the day-to-day Regulatory Affairs sustaining and compliance projects for medical devices by directly and indirectly managing teams of employees and contractors. This position entails a high degree of independent judgment and execution on plans that directly impact the operational results of the business unit.

In this role, you will:

  • Direct and coordinate activities concerned with medical device submissions and approvals to government regulatory agencies and notified bodies.
  • Provide guidance to project team members regarding regulatory compliance issues by providing independent regulatory guidance and support for strategic planning and compliance activities.
  • Oversee the preparation and maintenance of regulatory files
  • Act as the RA Lead for MDSAP audit and notified body surveillance audits.
  • 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 regulatory support of marketed products.
  • Interact with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.
  • Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
  • Be responsible for communicating business related issues or opportunities to next management level
  • Work with team members and commercial partners to oversee the regulatory aspects and carries out an RA assessment of the impact that product changes have on the status of regulatory licenses.
  • Interpret medical device regulatory requirements
  • Independently make decisions regarding work processes or operational plans and schedules
  • Ensure organization compliance with all applicable regulations and J&J policies
  • Provide day-to-day instructions and suggested training activities to direct reports
  • Assign projects or activities to individual contributors

  • Qualifications
  • A minimum of a Bachelor’s degree with at least 8 years of relevant experience is required.
  • Practical experience in a Medical Device Regulatory Environment is required.
  • Knowledge of US and European regulatory processes is required.
  • Experience with 510(k) submissions and/or Class II Technical files is required.
  • Experience working as a member of a team in a timeline-driven environment with limited supervision is required.
  • People management skills is preferred.
  • Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required.
  • Ability to partner and influence key stakeholders on Lifecycle teams is required.
  • Experience with Medical Device Regulation (MDR) is preferred.
  • Experience in change management is preferred.
  • Knowledge of international medical device requirements (China, Japan, Australia, Brazil, Russia, etc.) is preferred.
  • Excellent written, verbal communication and presentation skills.
  • This position is located in Palm Beach Gardens, FL; Oberdorf Switzerland; Zuchwil Switzerland; or remote (in the United States, United Kingdom, or Switzerland) for the right candidate.
  • 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.

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