We increase quality of life, enable personalized treatment, advance research and relieve our health system. * Preparing technical documents to support country-specific regulatory submissions of registration documents and maintaining, reviewing and updating regulatory submissions and documents * Preparing, reviewing, and maintaining SOPs, work instructions, and templates to ensure efficient and compliant regulatory processesEstablishing, maintaining, and regularly updating the company-wide Legal Register, including systematic identification and assessment of applicable regulatory requirements * Degree in medical technology, biology, biochemistry, or comparable course of study * Minimum of 4 years of experience in regulatory affairs in the context of (in-vitro diagnostic) medical devices (e.g. MDR, IVDR) * Very good command of German and English
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