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Senior Manager of Regulatory Affairs

  • Job type: Permanent
  • Location: Bridgewater, New Jersey
  • Salary: US$110000 - US$150000 per year
  • Job reference: 292681/001_1560983221
  • Sector: Pharmacology, EPM Scientific
  • Date posted: 19/06/2019

One of the world's leaders in medical technology is looking for a Senior Manager, Regulatory Affairs to join one of the most innovative Regulatory teams in the USA.

This team is seen as one of the world's leading medical device organization. A major driver of the company's growth is due to increased investment in cell and gene therapy enabling medical devices.

This company focuses on providing technologies that enable researchers and developers to create next-generation cell and gene therapies and supporting the manufacturing of cell-based therapies at every phase of development.

The Senior Manager of Regulatory Affairs will lead a team that will work to develop, drive and implement new regulatory strategies on both domestic and international projects.

Responsibilities Include

  • Management and filing of all domestic submission's regulations
  • Lead Regulatory Strategy Team on new and pre-existing projects
  • Serve as liaison to FDA
  • Prepare US (510k), PMA, IDE) submissions and technical files.
  • Experience authoring 510K submission is a requirement
  • Experience working with original PMA submission is highly preferred

Requirements:

  • 5-10 years of Regulatory Experience in Medical Devices.
  • Bachelor's Degree in science or health-related field.
  • Advance degree preferred (PhD, MD, MS, Pharm O, or equivalent)
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