We have revolutionized allergy diagnostics and have been operating successfully in more than 90 countries for over 9 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, reviewing and updating regulatory submissions and documents

· Evaluating regulatory input for CAPAs, changes, deviations, …

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

· Supporting internal and external audits and inspections

· Serving as the company's Data Protection Officer: ensuring compliance with applicable data protection regulations

· Establishing, maintaining and regularly updating the company-wide Legal Register, including systematic identification and evaluation of relevant legal requirements

· 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 with your CV!

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