vom 26.03.2026
We are seeking a Senior Medical Writer, experienced with medical devices.
Tasks: Lead the preparation and review of key medical device documentation, including PMCF plans/reports, PSURs, CERs, and PMS reports for class IIA, IIB and III medical devices. Conduct comprehensive literature searches and critically appraise scientific data to support regulatory and clinical documentation. Provide expert medical and scientific input across projects, ensuring compliance with MDR requirements and supporting transitions from MDD to MDR. Respond to regulatory authority queries with clear, evidence‑based medical justifications. Collaborate with cross‑functional teams to support study‑related documentation (protocols, study reports) for medical device projects. Participate in scientific meetings and stay updated on clinical and regulatory developments in the medical device field.
Requirements: We are looking for candidates who embody our values of Audacity, Care, and Energy and also: Degree in Life Sciences. Strong understanding of medical science, clinical practice, and the regulatory landscape for medical devices. Proven experience with medical writing for various classes of medical devices, including preparation of PMCF, PSUR, CER, and PMS documentation. Ability to interpret, evaluate, and translate complex medical research findings into clear, structured content. Experience with literature search methodologies and critical appraisal of scientific evidence. Excellent written and verbal communication skills, with the ability to convey complex information effectively. Additional experience in IVD regulatory writing is considered an asset. Fluent in English. Knowledge of French language is a plus.
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