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.