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Senior Clinical Affairs Manager 100% - Permanent position

Company

Multi Personnel

Location

bern, bern

Posted

June 24, 2026

Position Overview

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

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