Regulatory Affairs Specialist

Job Title

Responsibilities:

1. Prioritize and monitor cases throughout the day, provide status updates as necessary.
2. Support the IVDR labeling conversion and revisions of technical files for appropriate products that are due to convert to the new IVD Regulation.
3. Work cross-functionally in weekly meetings to ensure labeling conversion follows the plan.
4. Monitor monthly manufacturing schedule, track change requests and monitor manufacturing timelines.
5. Update labeling tracking log; ensuring accuracy of product lot numbers, RA regional notifications, follow-ups and product restrictions.
6. Update previous revisions of IVDR Technical Files to most current template, include necessary attachments.

Requirements:

• Bachelor's degree in scientific field; biology, biochemistry, medical technology or similar.
• 5+ years of experience in Reg Affairs, QA, R&D, Manufacturing, and/or Project Management within the IVD industry.
• Knowledge of FDA, and CE marking requirements for IVD products is preferred.
• Excellent verbal and written communication skills.
• Thorough knowledge of policies, practices and procedures related to Regulatory Affairs.