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.

• Taking Ownership for the Post Market Surveillance System by establishing, maintaining, and continuously improving the Post-Market Surveillance (PMS) system in accordance with IVDR requirements (e.g., PMS plans, PMS reports, PSURs)

• Set up and own a state-of-the-art Compliance Management System to ensure continued compliance with all relevant global standards

• Preparing, reviewing, and maintaining SOPs, work instructions, and templates to ensure efficient and compliant regulatory processes

• Acting as liaison to other departments with focus on collaboration with clinical on activities to ensure an up to date performance evaluation for all our devices

• Support in 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 input

• Assisting in responses to regulatory authorities, notified bodies and authorized representatives' questions within assigned timelines

• Supporting internal and external audits and inspections

• 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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