Medical Writer / Post-Market Surveillance Coordinator | Medical Writer / PMS Coordinator (m/w/d)
Bentley InnoMed GmbH
Job Summary
This role is a key part of an international team focused on developing innovative products for the minimally invasive treatment of vascular diseases. The successful candidate will primarily manage post-market surveillance activities, including drafting essential documentation such as PMS Plans and PSURs (Periodic Safety Update Reports). Day-to-day tasks involve supporting the creation of clinical evaluations, independently developing statements on specific scientific questions, and assisting other departments with writing test plans and reports. A crucial aspect of the job is working collaboratively with interdisciplinary teams to draft and review product labeling texts. The position requires a natural science or medical degree, proven experience in scientific writing, and comfort switching between German and English in daily business. Knowledge of regulatory documents like CEP, CER, SSCP, MDR, and MDCG is highly beneficial, making this an ideal opportunity for a detail-oriented professional seeking growth in the medical device sector.
Required Skills
Education
Completed degree in natural sciences or medicine
Experience
- Professional experience in scientific writing
- Experience in summarizing and evaluating clinical studies and publications
- Familiarity with regulatory concepts (CEP, CER, SSCP, PMS, PSUR, PMCF, MDR, MDCG)
Languages
Additional
- Not specified
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