Posted to MedZilla on 1/22/2020

EPM Scientific

US-NJ, Sr. Manager Regulatory Affairs - Medical Device 452431245054-MZ


Senior Manager of Regulatory Affairs – Medical Device

Location: New Jersey

Salary: $140,000-$160,000 + bonus + excellent benifits


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 the leading provider of surgical instruments including: devices, implants, and systems used in neuromontioring, neurosurgery, neurotrauma, and other similar care services giving medical providers the best tools in patient care.


The Senior Manager of Regulatory Affairs will lead a team that will work to develop, drive and implement new Regulatory Strategy on both domestic and international projects. Projects will be led to follow international and domestic FDA regulations: ISO 9001 Standards, ISO 13485:2003, as well as other International Regulations. There will also be exposure to Asian markets, so any previous experience in this area is highly valued.


The ideal candidate will have the following responsibilities:
  • Management and filing of all international regulations
  • Lead Regulatory Strategy Team on new and pre-existing projects
  • Serve as liaison to International and Domestic Health Authorities
  • Review product complaints
    • MDR Reporting
    • Field Safety Corrective Action
    • Daily regulatory operations submissions

  • 4-8 years of Regulatory Experience in Device, Drug, or Biologics
  • OUS Experience
    • PMDA
    • KFDA
    • SFDA

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