Senior Regulatory Affairs Specialist

Location: Schaumburg, Illinois, United States
Salary: US$90000 - US$110000 per annum + + Bonus
Job Type: Permanent
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Our company is currently partnering with a global Medical Device company based in Schaumburg, Illinois with hiring for a Senior Regulatory Affairs Specialist. This is a full time direct-hire position that reports to the Vice President of Regulatory Affairs and Quality Assurance.

The Senior Regulatory Affairs Specialist will be responsible for the life-cycle management of Class I and Class II medical devices. This is a global position and this person will directly communicate with Regulatory Agencies and Notified Bodies. This person will work cross functionally to support day to day Regulatory activities. This person will lead all 510(k) and global submissions. The Senior Regulatory Affairs Specialist will also be responsible for the EU MDR 2020 project.

The Senior Regulatory Affairs Specialist will also get exposure supporting the ISO 13485 Quality System.

The Salary for this position is $90,000 - $110,000 + Bonus

Here are some of the requirements:

Education:

  • 4 Year Bachelor's Degree, Life Sciences Preferred
  • Higher Education is a plus
  • RAC Certifications are a plus

Experience/Expectations:

  • 4+ Years of Regulatory Experience with Medical Devices
  • Author of 1 or more 510(k)'s and Tech Files
  • Strong MDD/MDR experience
  • Life Cycle management experience with Medical Devices
  • Proven experience of working Cross-Functionally
  • Strong written and verbal communication skills

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

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

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