Minimum of 4 years of experience in regulatory affairs in the context of (in-vitro diagnostic) medical devices (e.g. MDR, IVDR) * Preparing technical documents to support country-specific regulatory submissions of registration documents and maintaining, reviewing and updating regulatory submissions and documents * Evaluating regulatory impact for CAPAs, changes, and deviations, and providing strategic regulatory inputAssisting in responses to regulatory authorities, notified bodies and authorized representatives' questions within assigned timelines * 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
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