Regulatory Affairs Professional (m/f/d) Medical Devices

About this role

Ein im Bereich Healthcare Diagnostics tätiges Tochterunternehmen eines weltweit erfolgreichen Technologiekonzerns in Wien sucht 1 Regulatory Affairs Professional (m/f/d) Medical Devices im Ausmaß von 38,5 Stunden / Woche, Location: Hybrid Role in one of our offices: Budapest, Vienna, Warsaw Join our Regulatory Affairs team and help ensure the successful market access and compliance of our products across Austria and selected CEECA markets.

In this role, you will work closely with internal and external stakeholders to navigate regulatory requirements and support key business activities. Your Responsibilities: * Coordinate product registrations and registration updates with distributors, consultants, and business partners. * Collect, review, and manage regulatory documentation required for market access, import, and distribution. * Monitor changes in local regulatory requirements and assess their business impact.

* Support certifications, licenses, notifications, and other regulatory activities. * Collaborate closely with business lines, external partners, and authorities on regulatory matters. * Maintain accurate documentation, project tracking, and regulatory records. * Support post-market surveillance, post-market control activities, regulatory audits, and inspections to ensure ongoing compliance with applicable requirements.

* Contribute to PCN assessments and support the development, implementation, and continuous improvement of regulatory SOPs, work instructions, and internal processes. Your Profile: * Experience in Regulatory Affairs within the Medical Device, In Vitro Diagnostic (IVD), Pharmaceutical, or another highly regulated industry. * Knowledge of EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is considered a strong advantage.

* Strong attention to detail and a structured approach to managing documentation, compliance requirements, and regulatory processes. * Ability to effectively prioritize multiple tasks and meet deadlines in a fast-paced and dynamic environment. * Excellent analytical, critical-thinking, and problem-solving skills. * Strong interpersonal and communication skills, with the ability to collaborate effectively with both internal and external stakeholders.