Regulatory Affairs Specialist II

Responsibilities:

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

Requirements and Desired Experience:

• Bachelor’s degree in scientific field; biology, biochemistry, medical technology or similar
• 3 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