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Regulatory Affairs Project Manager

  • Job type: Permanent
  • Location: New Jersey
  • Salary: $130000 - $170000 per annum
  • Job reference: MSLN534062717
  • Sector: EPM Scientific, Regulatory
  • Date posted: 27/06/2017
Role: Regulatory Affairs Project Manager
Location: New Jersey
Salary: $1300,000 - $170,000 + bonus + excellent benefits + relocation

One of the world's leading medical technology companies is looking for a Regulatory Affairs Project Manager to join their growing team. This medical technology company offers innovative medical technologies, including spine products to help people lead more satisfying lives. 

Key Responsibilities
  • Ensure compliance with all US, EU and Spine requirements as well as procedures regarding submissions and other requirements for approval of medical devices
  • Author submissions and other regulatory documents to obtain approval to bring new or modified products to market including but not limited to 510(k)s, IDEs, PMAs, and Design Dossiers
  • Coordinate with the FDA, Notified Bodies, Competent Authorities, and other regulatory agencies on submissions.
  • Plan, organize and implement strategies required to procure regulatory approval for new and revised product lines.
  • Be the regulatory voice for the spine group, along with having about 10m people who will be directing to you
The successful candidate will have:
  • 4 year degree in scientific area preferred
  • 510(k), IDE, PMA preparation experience
  • 4-5 Years experience in regulated medical device industry
  • Experience managing a team
  • Working knowledge of FDA and EU Medical Device Regulations
If this Regulatory Affairs Project Manager role interests you and you want to learn more, apply now! 

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