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Sr. Regulatory Affairs Specialist
A medical device company, located northeast of Pittsburgh, is seeking a Sr. Regulatory Affairs Specialist. Responsibilities: Responsible for maintaining a cGMP compliant Quality Management System for a Medical Device manufacturer's implemented systems to ensure the Quality System is established and maintained in accordance with FDA 21 CFR 820, cGMP, MDD 93/42/EEC, MDR 2017/745, and ISO 13485 regulatory requirements. Involvement in the maintenance and improvement of the Regulatory environment including the FDA, CE, and related country regulatory requirements globally. Prepare and maintain regulatory submissions. Maintain country specific product registrations. Analyze product changes for impact to current regulatory filings.


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