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 country-specific 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, 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)
• Advantageous: Experience with regulations and registrations in USA, Canada and/or Japan or Experience in Post-Market Surveillance (PMS) activities.
• Accuracy, willingness to learn and the ability to work independently, competence to work in a team
• Very good command of German and English

• A full-time position, flexible working hours, home office if necessary
• Annual pass for Vienna's public transport and Sodexo vouchers
• Collaboration with people who care about human and veterinary patients alike
• An environment where you feel empowered to ask questions, make requests and offer ideas
• An atmosphere created by the thoughts of sustainability, equity, diversity, inclusion, and mutual respect

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