Description

Leads the integrated Post Market Quality Assurance and Clinical Affairs functions, ensuring a compliant, effective QMS; timely identification and management of post-market signals; and development of clinical evidence supporting product safety, performance, and lifecycle decisions. Key areas include:

Post-market surveillance, complaints, vigilance, MDRs, recalls, field actions, and EUDAMED reporting
Clinical strategy, evidence planning, evaluations, literature reviews, and state-of-the-art assessments
Post-market clinical follow-up (PMCF) planning and reporting
Clinical investigations, external research, and clinical support for submissions, claims, and risk management

Director, Post Market Surveillance and Clinical Affairs

Description

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