BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs and/or related experience * Strong experience in regulatory affairs and quality management, preferably in medical devices, ideally with experience in standalone or embedded medical device software and IEC 62304, or in pharma * Experience with FDA requirements and successful submissions (e.g., 510(k) and FDA audits) in addition to knowledge regarding digital processes in RA (incl. submissions, digitalization and intelligence)
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