Junior Regulatory Affairs Manager (w/m/d) - Medical Devices

We have revolutionized allergy diagnostics and have been operating successfully in more than 90 countries for over 7 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 (DMFs, STDs, TD ); and maintaining/updating regulatory submissions/documents
• Communicating regulatory submission 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
• Supporting the QM department in the maintenance of the QM system according to EN ISO 13485:2016 and in implementing regulatory requirements regarding the QM system
• Carrying out post-market surveillance activities and prepare work instructions (SOPs) and forms

• Degree in medical technology, biology, biochemistry, or comparable course of study
• Advantageous: Experience with QM according to ISO 13485 and national/international registrations (Austrian MPG, IVDR, 510(k), ANVISA, MDSAP )
• Accuracy and willingness to learn
• 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 contact us with your CV and/or open questions at
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