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Senior Regulatory Affairs Specialist

Do you have a strong background within Regulatory Affairs? Are you interested in working at a leading medical device company? If you answered "Yes" to these questions, I have the perfect opportunity for you!

My client, a global healthcare company that specializes lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition, is actively searching for a Senior Regulatory Affairs Specialist to join its team in Lake Zurich, Illinois. This will be structured as a 1 year and 6 month contract and pay is $50-$65 per hour. They are looking for a Senior Regulatory Affairs Specialist to act as regulatory liaison for the medical device division and interact with the regulatory representative in countries around the world.

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

  • Prepare worldwide submissions for new products and any product changes as needed to ensure timely approval for market release
  • Find, interpret, and prepare regulatory strategies and worldwide compliance requirements
  • Maintain regulatory product reports to provide a regulatory analysis of product portfolio and be able to review with other functional resources

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

  • B.S. or higher in a technical discipline
  • 5-8 years of experience in the medical device industry
  • Experience authoring a 510k submission
  • Experience & knowledge of U.S., European, and International regulatory requirements
  • Experience working with CE Mark products and technical files

The Senior Regulatory Affairs Specialist is an outstanding opportunity to take on immediate leadership and grow within a top notch organization, and Lake Zurich, 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.