Senior Clinical Affairs Specialist - Dialyse Machines
Nipro Europe Group Companies
About the role: You will be working in a team that develops clinical evaluation reports (CERs) per MEDDEV 2.7.1 Rev 4 and MDR regulations (MDCG 2020-6). Your work will support CE Mark applications, recertifications, and proposed indication/labeling changes, ensuring EU product conformance. You will also develop and review Post Market Clinical Follow-up (PMCF) strategies, participate in Risk Management assessments, and Post Market Surveillance (PMS). What you’ll need: Experience in developing Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) Strong skills in conducting systematic literature research Ability to develop and execute PMCF plans and reports Proficiency in safety data analysis and reporting Experience in organizing and executing clinical trials Excellent collaboration skills with cross-functional teams #J-18808-Ljbffr
Vacancy posted 4 days ago
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