Senior Regulatory Affairs Specialist

Responsible for supporting regulatory activities regarding released product, including, MDR investigations submissions, post market risk assessments (HHA), supports maintenance of the product Technical File in support of CE Marking, and risk management file updates. Leads field safety corrective actions/recalls, as required. Serves as a liaison between QA and manufacturing, R&D, customer service, and customers regarding complaint investigations, the identification of root cause, and the recommendation/coordination of Corrective/Preventative Action(s), when required.