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Regulatory Affairs Associate

Location: Lake Forest Salary: US$25 - US$27 per hour + competitive
Sector: Pharma & Biotech, Medical Devices, Regulatory Affairs, Regulatory Affairs Type: Contract

Do you have a strong background within the medical device industry? Are you interested in working at a leading Pharma 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 Pharma and Life Science Company that specializes in medical devices, nutrition, and branded generic pharmaceuticals, is actively searching for a Regulatory Affairs Associate to join its team in Lake Forest, Illinois. This will be structured as a 12 month contract and will pay $25 to $27 per hour based on level of prior experience.

This Pharma and Life Science device Company is an organization serving over 99,000 employees across 150+ countries specializing in cardiovascular, diabetes, diagnostics, neuromodulation, nutrition, and pharmaceuticals. They are looking for a Regulatory Affairs Associate to interact with multiple departments and review critical documents and report for completeness and suitability for submission. This individual will work to think of solutions to overcome problems in order to hit submission goals for medical devices and branded generic pharmaceuticals.

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

  • Authoring and submitting PMA supplements, Real-Time Reviews, and 180-Day Supplements.
  • Review and approval of manufacturing changes for Class III implantable medical devices
  • Manage technical file changes, reviews labeling changes for completeness and suitability for submission.
  • Assure the regulations and laws regarding 510k and PMA submissions meet compliance.
  • Review engineering change requests to assess impact to regulatory submissions and responsible for writing import authorization memos to release ship flags to international countires.

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

  • B.S. or higher in Science, Biology, or Chemistry preferred
  • At least 3-5 years of work experience and experience in post-market regulatory tasks
  • Needs experience with quality systems, FDA PMA guidance documents, CFR regulations, change control, labelling review, and compliance
  • Experience with medical devices, regulatory, and submissions is a big plus

The Regulatory Affairs Associate is an outstanding opportunity to take on collaborative position and grow within a top notch organization, and Lake Forest, 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.