Senior Regulatory affairs specialist Job

• Gain in-depth understanding of the client’s global change control process.

• Review and assess change plans related to product labeling updates.

• Evaluate implemented labeling changes, including Instructions for Use (IFU), for accuracy and compliance.

• Collaborate with cross-functional teams to ensure proper execution and alignment of labeling changes.

• Work closely with the Technical Publications team to ensure timely publication of regulatory-compliant product labeling.

• Contribute to the development and review of performance testing documentation.

• Provide strategic guidance on equivalence assessments, usability evaluations, and human factors testing.

• Serve as a core team member supporting IFU development activities.

• Assist with technical file creation and updates in alignment with 510(k) clearances.

• Support the transition and migration from legacy documentation to updated product files.

• Evaluate and review product labeling change plans for in vitro diagnostic products to ensure accuracy and regulatory compliance.

• Validate and verify the accuracy of labeling changes implemented across various product lines.

• Collaborate with the Technical Publications team to ensure timely publication of compliant product labeling.

• Support global change control processes by working cross-functionally with teams including Quality, R&D, Product Transfer, and Clinical Affairs.

• Ensure ongoing regulatory compliance through effective cross-functional coordination and documentation oversight.

Bachelor's Degree is required in Regulatory Affairs or Technical Writing.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave