Regulatory Affairs Specialist

Do you have a strong background within the medical device industry? Are you interested in working at a leading Pharmaceutical and Life Science company with exciting growth plans? If you answered "Yes" to these questions, I have the perfect opportunity for you!

My client, a top Medical Device company that develops and supplies clinical diagnostics to the pathology market, is actively searching for a Regulatory Affairs Specialist to join its team in Richmond, Illinois. This individual will prepare and compile documentation and technical files for global medical device registrations.

Among others, this role will take on the following responsibilities:

  • Manage technical file changes, reviews labeling changes for completeness and suitability for submission.
  • Review engineering change requests to assess impact to regulatory submissions.

The best candidates for this role will possess the following basic qualifications:

  • B.S. or higher in Science, Biology, or Chemistry preferred
  • At least 2-4 years of work experience within medical device industry
  • Experience with preparation and submission of Declaration of Conformity (DOC)
  • Familiarity with processing licenses in the European Union and other regulatory bodies

The Regulatory Affairs Specialist is an outstanding opportunity to take on collaborative position and grow within a top notch organization, and Richmond, IL is a fantastic location!

If you are interested in learning more and/or applying, please reach out to me on the details below!

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