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

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.

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 thoughts 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, 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

Your profile

•

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

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 at our website!