Job Description

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:

• Remediate and update regulatory documentation to ensure compliance with U.S. 510(k) and EU MDR requirements.
• Develop and maintain global, regional, and multi-country regulatory strategies aligned with business objectives.
• Assess regulatory requirements and potential market access challenges, providing solutions to ensure timely approvals and product distribution.
• Review and evaluate preclinical, clinical, and manufacturing changes for regulatory filing needs.
• Collaborate with cross-functional teams and regulatory authorities on complex issues throughout the product lifecycle.
• Provide regulatory guidance on product claims, labeling, and strategy for submissions.
• Monitor regulatory changes and assess their impact on preapproval and postmarket strategies.
• Support preparation and training of teams for regulatory meetings, panels, and advisory committees.

Qualifications:

• Bachelor’s degree in a scientific or engineering discipline (advanced degree preferred).
• 5+ years of experience in regulatory affairs within the medical device industry.
• Strong knowledge of U.S. FDA 510(k) and EU MDR requirements for Class IIa devices.
• Proven ability to develop regulatory strategies and manage documentation remediation.
• Excellent communication, organizational, and analytical skills.
• Experience interfacing with regulatory authorities and cross-functional teams.

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