JOIN MEDIT – A GLOBAL LEADER IN 3D DIGITAL SOLUTIONS!

Medit is a global provider of cutting-edge 3D intraoral scanners and an all-in-one digital dentistry platform, powered by our patented state-of-the-art technology. We are committed to innovation and developing solutions that empower collaboration between dental clinics and labs.
As the first and only intraoral scanner in the world compatible with both Windows and Apple macOS operating systems, Medit continues to disrupt the dental technology industry with its customer-focused, affordable, and forward-thinking solutions.

[POSITION OVERVIEW]

Job Title: Sr. Regulatory & Quality Affairs Specialist – EU MDR Compliance & PRRC
Operational Reporting To: Chief Commercial Officer (CCO)
Functional Reporting To: Director of Regulatory Affairs & Quality Systems (RAQS) at Medit Corp. HQ in Korea
Work Location: Medit Europe GmbH

EDUCATION

• Bachelor’s degree in Biomedical Engineering, Healthcare, or a related field.
• Certification in regulatory affairs, such as RAC – European Union preferred.

EXPERIENCE

• Minimum of 8+ years of experience in regulatory affairs, including EU MDR compliance and PRRC responsibilities.
• Hands-on experience with medical devices, covering both hardware and SaMD..
• In-depth knowledge of EU MDR requirements, post-market surveillance, vigilance reporting, and risk management standards (ISO 14971).
• Proven experience preparing regulatory submissions and working with Notified Bodies.
• Familiarity with medical device standards such as IEC 60601 (hardware), IEC 62304 (SaMD), and ISO 13485.
• Experience managing conformity assessments and audits with Notified Bodies is preferred.
• Familiarity with EU regulatory databases, including EUDAMED,is preferred.
• Knowledge of importer and distributor obligations under EU MDR is preferred.
• Proficiency in post-market processes, including PSUR and SSCP preparation, is preferred

SKILLS

• Strong communication and organizational skills, with the ability to collaborate across cross-functional teams.

PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)

• Serve as the PRRC under EU MDR Article 15, ensuring product compliance before market release.