Regulatory Specialist

Regulatory Affairs Specialist

12-month contract

Remote CST hours (Local to Cary, IL is preferred)

Must be able to work on a W2

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.