Principal Regulatory Affairs Specialist
6 month contract
On-site in Cary, IL
Must be able to work on a W2
Job Summary:
We are seeking a Regulatory Affairs Specialist to support global regulatory strategy and compliance activities for Class IIa medical devices. This role will focus on documentation remediation for U.S. 510(k) and EU MDR Technical Files, evaluating regulatory risks, and developing solutions to support product approvals and market access. The ideal candidate will partner cross-functionally to ensure clinical, nonclinical, and labeling materials align with evolving regulatory requirements.
Job Responsibilities:
Qualifications:
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