Senir Regulatory Affairs Specialist

Location: Lake Forest, Illinois, United States
Salary: US$80000 - US$90000 per annum + competitive
Job Type: Permanent
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We are currently partnering with a Global Medical Device Company with hiring a Senior Regulatory Affairs Specialist. This is a permanent direct-hire position that will report into the Director of Regulatory Affairs. This company is located in Lake County, IL and is able to virtually interview and on-board.

The Senior Regulatory Affairs Specialist will support the life-cycle management for Class II Medical Devices. This is a global position and this person will be able to create their own Regulatory Strategy for multiple product lines. This person will be able to gain experience with 510(k)'s, Tech Files, and other global submissions.

The Senior Regulatory Affairs Specialist should have experience supporting medical devices on a global scale. This person should have proven experience supporting the MDD to MDR transition.

The available salary for this position is $90,000 + 5% Bonus

Requirements:

  • 4 year Bachelor's Degree, Life Sciences
  • 3-5 Years of Regulatory Experience in the Medical Device Industry
  • Experience Writing and Supporting 510(k) Submissions
  • Experience performing MDR 2020 Transition
  • Global Registration and Submissions to LATAM, APAC, EU, Health Canada

If you are interested in this opportunity, please send me your updated resume and availability for phone screen. Interviews will begin next Wednesday.

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

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