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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.
Job Description
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