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

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 clarify allergies in a single step – for humans and animals alike. Allergies are diagnosed in a highly specific manner so that patients receive help from their specialist promptly. We increase quality of life, enable personalized treatment, advance research, and relieve our health system.

We Offer

• 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 values of sustainability, equity, diversity, inclusion, and mutual respect

We Need You For

• Preparing technical documents to support country-specific regulatory submissions of registration documents, and maintaining and updating regulatory submissions and documents
• Communicating regulatory requirements to other departments
• Providing input to Product Design teams to ensure that regulatory standards are met
• Evaluating regulatory input for CAPAs, changes, deviations, etc.
• 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 the regulatory landscape
• Ensuring compliance with applicable legislation
• Carrying out post-market surveillance activities and preparing work instructions (SOPs) and forms

Your Profile

• Degree in medical technology, biology, biochemistry, or a comparable field of study
• Minimum of 4 years of experience in regulatory affairs related to (in-vitro diagnostic) medical devices (e.g., MDR, IVDR)
• Advantageous: Experience with regulations and registrations in the USA, Canada, and/or Japan
• Accuracy, willingness to learn, ability to work independently, and competence to work in a team
• Very good command of German and English

For cooperation in our team, we offer a salary aligned with the 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 please contact us with your CV.