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  

 

 

 

[Key Responsibilities]  

Regulatory Submissions 

• Prepare and submit regulatory submissions for both hardware and Software as a Medical Device (SaMD) to Notified Bodies and regulatory authorities.  

Person Responsible for Regulatory Compliance (PRRC)  

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

Post-Market Surveillance (PMS)  

• Oversee PMS activities, including vigilance reporting, preparation of Periodic Safety Update Reports (PSUR), and managing corrective actions to address safety or performance issues.  

Regulatory Monitoring & Policy Updates  

• Monitor and evaluate changes in EU MDR and global regulatory requirements, ensuring internal policies and practices remain compliant and up-to-date.  

External Liaison  

• Support interactions with regulators, Notified Bodies, and auditors during conformity assessments, surveillance audits, and product reviews.  

Technical Documentation & MDR Alignment  

• Collaborate with cross-functional teams to maintain technical documentation in line with EU MDR requirements.  

Quality System Management  

• Assist in managing quality systems for importation and distribution, including working with third-party logistics providers (3PL).  
• Develop and maintain Standard Operating Procedures (SOPs) to ensure robust quality management systems in line with MDR regulations.  

Licenses & Registrations  

• Manage annual licenses, registrations, and listings for devices regulated under EU MDR.  

 

 

 

[Qualifications] 

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. 

 

 

 

[Key Attributes]  

• Cultural Builder: Create and nurture a high-performance, employee-centered culture.  
• Problem Solver: Analyze regulatory and quality affair-related challenges and implement effective solutions.  
• Collaborative Leader: Work closely with global teams and senior management.  
• Adaptable: Thrive in a dynamic, startup-like environment with evolving priorities.  

  

 

 

  

[Selection Process]  

• CV Screening > Interview Rounds > Salary Negotiation > Onboard  

  

In case you do not have a resume, you may download the MEDIT resume template below.  

Job Application  

The following position is screened on a rolling basis and may close once the position is filled.  

Any false information in the resume may lead to termination of the employment contract.  

  

Learn more about MEDIT:  

MEDIT Career Page  

MEDIT Official Youtube Channel