Regulatory Affairs Professional (M/F/D) Medical Devices

Opis stanowiska

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

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

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.
• Professional working proficiency in English and German.

What else do I need to know?

According to the EU Pay Transparency Directive, we are required to disclose salary information for certain countries.

• For candidates applying from Austria, the minimum gross annual salary for this position is EUR 50,000.00. Depending on qualifications and professional experience, a higher salary may be offered.

Who we are:

We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.