Senior Regulatory Affairs Specialist

Location: McHenry, Illinois, USA
Salary: US$80000 - US$90000 per annum + competitive
Job Type: Permanent
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We are currently partnering with a Global Medical Device and Pharmaceutical company with recruiting for a Senior Regulatory Affairs Specialist to join their team. The Senior Regulatory Affairs Specialist will report to the Manager of RA. This is a Permanent Direct-Hire position located in the Northwest Suburbs of Chicago.

The Senior Regulatory Affairs Specialist will be responsible for the life-cycle management of Medical Devices, Pharmaceuticals, and Cosmetics. This person should be well versed with US and OUS regulations. The Senior Regulatory Affairs Specialist will work closely with cross-functional groups with supporting an emerging market strategy.

This person should be well versed in Device or Pharma, but willing to learn the other. This company offers a lot of opportunities to grow your Regulatory skills at a global scale.

The available salary for this position is $80,000 - $90,000 + Bonus

Education:

  • 4 Year Bachelor's Degree, Life Sciences Preferred
  • Higher Education or RAC is a Plus

Experience/Expectations:

  • 3+ years of Regulatory Experience in Device or Pharma
  • Experience with US Submissions such as 510(k)/NDA/ANDA
  • Experience with Non-US Regulations
  • Background in quality/engineering is a plus
  • Proven experience with Design Control/Change Control

If you are interested in this position please send me your updated resume and availability for a phone screen.

Sthree US is acting as an Employment Agency in relation to this vacancy.

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