Regulatory Affairs Manager (f/m/x) Medical Devices

We have revolutionized allergy diagnostics and have been operating successfully in more than 90 countries with our diagnostic products and patented technologies. Our products help clarifying allergies in a single step – for humans and animals alike. Allergies are diagnosed in a highly specific manner so that patients receive help by their specialist in no time. We increase quality of life, enable personalized treatment, advance research and relieve our health system. Preparing technical documents to support countryspecific regulatory submissions of registration documents and maintaining, reviewing and updating regulatory submissions and documents Establishing, maintaining, and continuously improving the Post-Market Surveillance (PMS) system in accordance with IVDR requirements (e.g., PMS plans, PMS reports, PSURs) 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 Supporting internal and external audits and inspections Preparing, reviewing,

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