Person responsible for regulatory compliance (PRRC)

We are hiring a Person Responsible for Regulatory Compliance (PRRC)Location: Slovenia (Remote or Hybrid arrangement possible)We are looking for an experienced and motivated PRRC to join our team and ensure full compliance with the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). This is a key role for supporting regulatory integrity and quality across the entire product lifecycle. Key responsibilities include:

• Ensuring continuous compliance with MDR and IVDR requirements • Overseeing technical documentation, conformity assessments, post-market surveillance, and vigilance activities • Acting as the main contact for notified bodies and competent authorities • Supporting the quality management system in line with ISO 13485 • Providing regulatory guidance and support across teamsWhat we expect: • Proven experience in regulatory affairs for medical devices or in vitro diagnostics • Strong understanding of MDR and IVDR requirements • Familiarity with ISO 13485 and QMS processes • Excellent communication skills in both Slovenian and English • A proactive, responsible, and detail-oriented mindsetWhy join us:

• Work with a team of experts on impactful and meaningful projects • Flexible work environment • Opportunities for continuous professional development • Be part of a company that values both compliance and innovationIf you are based in Slovenia and ready to take the next step in your regulatory career, we would be happy to hear from you.