Regulatory Affairs Specialist (m/f/d)

It feels good to know that your work makes a difference. At Artivion, we develop and manufacture innovative medical devices and solutions for the treatment of aortic diseases. Together with surgeons around the world, we help save lives. We value the individual strengths of every team member, and your expertise can make a meaningful contribution to our mission. Bring your strengths to Artivion and grow with us.

We are looking for a

Regulatory Affairs Specialist (m/f/d) – EU MDR & Digitalization – Remote

Your Strength

• University degree in science, engineering, or a related technical field, or an equivalent qualification
• Ideally 3–5 years of professional experience in medical device Regulatory Affairs
• Solid knowledge of the EU Medical Device Regulation (MDR), particularly Technical Documentation, conformity assessment, and regulatory compliance
• Experience with Class IIa, IIb, or III medical devices; international regulatory experience is an advantage
• Practical experience using AI-based tools for regulatory research, requirements analysis, documentation reviews, or similar activities
• Strong affinity for digital technologies and structured data, with the ability to translate complex regulatory requirements into clear and verifiable criteria
• Strong analytical skills, independent judgment, and a proactive, solution-oriented approach to improving regulatory processes
• Very good English communication skills; German is an advantage

Your Contribution

• Independently manage regulatory activities for new medical device approvals, maintenance of existing certifications, and ongoing EU MDR compliance
• Prepare, review, and maintain Technical Documentation and regulatory submissions in accordance with applicable requirements
• Assess regulatory requirements and product changes in close collaboration with international Regulatory Affairs teams and cross-functional experts
• Address complex regulatory questions and support communication with Notified Bodies and Competent Authorities
• Support international product registrations, regulatory lifecycle activities, and relevant quality management processes
• Apply AI-based and digital tools to improve regulatory research, documentation reviews, consistency checks, and regulatory assessments
• Translate regulatory requirements into structured review criteria and reproducible assessment processes, improving the traceability and reuse of regulatory information
• Identify opportunities to simplify workflows, reduce repetitive tasks, and improve regulatory process efficiency and quality
• Critically evaluate AI-supported results for accuracy, completeness, and regulatory reliability, ensuring appropriate human oversight
• Share practical experience and contribute to the responsible adoption of digital technologies within Regulatory Affairs

Our Strength

• Independent and responsible role with the opportunity to actively shape and improve regulatory processes
• Structured onboarding and ongoing support from experienced colleagues
• An internationally successful medical device company with innovative products and a meaningful mission
• An open, collaborative team and close cooperation with international colleagues and cross-functional experts
• Fully remote work within our eligible European employment locations
• The opportunity to contribute your ideas and actively drive digital transformation within Regulatory Affairs
• Individual development opportunities and long-term career prospects

Location & Eligibility

This position is fully remote and open to candidates based in the United Kingdom, Belgium, the Netherlands, Germany, Italy, Poland, Spain, Austria, Switzerland, subject to applicable local employment arrangements and operational requirements.

Applicants must already have the legal right to work in their respective country of employment. Artivion does not provide visa sponsorship or work permit assistance.

Contact

Apply now and join the Artivion team. We are looking forward to receiving your application documents directly via our online system.

Leonie Herrmann, T: 07471 9713571

JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen

www.artivion.com

Apply now and join the Artivion team. We are looking forward to receiving your application documents directly via our online system.

Leonie Herrmann, T: 07471 9713571

JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen

www.artivion.com

Originally posted on Himalayas