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Regulatory Compliance Manager

  • Type Permanent
  • Salary US$10900 - US$130000 per annum + competitive
  • Location Bloomingdale, Illinois
  • Sectors Regulatory Affairs (RA)

We are currently recruiting for a Regulatory Compliance Manager for a Class II Medical Device company in Dupage County, IL. This is a permanent Direct-Hire position for a Medium Sized company. This person will be the Regulatory and Quality lead for the full life-cycle management for these devices. This is a global position, focusing on North America, EU, LATAM, and other global markets.

The Regulatory Compliance Manager will be the lead for the entire RA/QA team. This person will have direct reports and will help shape and improved the RA/QA department. The Regulatory Compliance Manager will maintain the ISO 13485:2016 Quality System, support MDSAP, and be the main point of contact for those audits.

The Regulatory Compliance Manager will also help guide the team with Global Regulatory Submissions such as 510(k)'s and Tech Files. This person will help create a successful Global Regulatory Strategy for the second generation of this company's medical Devices. This strategy will help identify which markets the company should work in next.

The salary range for this position is up to $130,000

Education Requirements:

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

Experience/Expectations:

  • 5+ Years of Regulatory and Quality Experience
  • Implemented ISO 13485:2016 Quality System
  • Acted as Management Representative for Audits
  • Experience with MDSAP and MDR 2020
  • Full Life Cycle Management of Medical Devices Experience
  • Familiarity with 510(k) and Tech File Submissions
  • Strong Project Management and Leadership Experience

If you are interested please send me a copy of your updated resume and availability for a phone screen.

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