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.
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 Official Youtube Channel
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.
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 Official Youtube Channel