What are the responsibilities and job description for the Regulatory Affairs Specialist II position at Cypress?
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
Salary : $70,000 - $115,000