Principal Regulatory Affairs Specialist

Prepare Global submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager and negotiate submission issues with agency personnel. Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare and support submissions and reports for various Regulators as required by product status. Review only significant submission decisions/content issues with manager. Interact directly with Regulators and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager. Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed. Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.

According to JobzMall, the average salary range for a Principal Regulatory Affairs Specialist in 2343 W Medtronic Way, Tempe, AZ 85281, USA is between $91,000 and $114,000. This range can depend on a variety of factors, such as experience, education level, and industry.

Medtronic plc is the world's largest medical device company that generates the majority of its sales and profits from the US healthcare system and is headquartered on the island of Ireland.