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.
Preparing technical documents to support country-specific regulatory submissions of registration documents and maintaining, reviewing and updating regulatory submissions and documents
Establishing, maintaining, and continuously improving the Post-Market Surveillance (PMS) system in accordance with IVDR requirements (e.g., PMS plans, PMS reports, PSURs)
Evaluating regulatory impact for CAPAs, changes, and deviations, and providing strategic regulatory inputAssisting in responses to regulatory authorities, notified bodies and authorized representatives' questions within assigned timelines
Supporting internal and external audits and inspections
Preparing, reviewing, and maintaining SOPs, work instructions, and templates to ensure efficient and compliant regulatory processesEstablishing, maintaining, and regularly updating the company-wide Legal Register, including systematic identification and assessment of applicable regulatory requirements
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
JBRP2_AT