Senior Clinical Affairs Manager

Responsibilities

• Development and implementation of the clinical strategy for the entire product portfolio
• Creation, review and maintenance of Clinical Evaluation Reports (CER) in accordance with MEDDEV 2.7/1 Rev. 4 and MDR Annex XIV
• Conduct of systematic literature searches and critical appraisal of clinical evidence and state-of-the-art analyses
• Independent planning and execution of Post-Market Clinical Follow-up (PMCF) activities including PMCF Plan and PMCF Evaluation Report
• Authoring and review of clinical study protocols according to ISO 14155 and GCP
• Close collaboration with Regulatory Affairs in the creation and maintenance of technical documentation (Technical Files)
• Clinical input for PMS processes, PSURs, and support of regulatory submissions and communication with Notified Bodies
• Professional guidance and mentoring of junior team members and active knowledge sharing within the team