Regulatory Affairs Manager (w/m/d)

We have revolutionized allergy diagnostics and have been operating successfully in more than 90 countries for over 8 years 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 andupdating regulatory submissions anddocuments
• Communicating regulatory requirements to other departments
• Providing input to Product Design teams to assure that regulatory standards are met
• Evaluating regulatory input for CAPAs, changes, deviations,
• Assisting in responses to regulatory authorities, notified bodies and authorized representatives' questions within assigned timelines
• Staying up to date with regulatory procedures and changes in regulatory climate
• Ensuring compliance with applicable legislation
• Carrying out post-market surveillance activities and preparing work instructions (SOPs) and forms

• 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
• 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

For the cooperation in our team, we offer a payment in line with collective agreement (KV Handwerk und Gewerbe) based on a full-time position. Your actual salary depends on your previous experience and qualifications. Ready to become part of the MADx team? Then apply via Linkedin or contact us with your CV and/or open questions at .

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