About this role
Are you ready to take ownership of certification projects that bring safe, innovative medical devices to patients worldwide? DNV Medical Devices is looking for a Project Controller to join our Project & Customer Management Team in Seoul.
In this role, you will manage medical device certification projects under EU MDR, EU IVDR, MDSAP and ISO 13485, from the first client application through to certificate issuance. You will be the key link between Korean manufacturers, our auditors and technical reviewers, and DNV's Global Certification Unit (GCU), making sure every project is delivered on time, in compliance with regulatory and accreditation requirements, and with an excellent customer experience.
This is a one year time-bound contract opportunity, and interested candidates are encouraged to apply at the earliest.
<What You Will Do>
- Manage certification projects end to end, from application review, certification planning and agreements through to certificate issuance.
- Plan and coordinate schedules of QMS audits, technical documentation assessments with auditors/assessors and customers.
- Keep project data accurate in DNV's production systems, and manage invoicing.
<About The Team>
You will join the team in Korea supporting a portfolio - hundreds of Korean medical device manufacturers seeking access to the EU and global markets. You will work with the local connections in Korea and global connections in Europe.
- The opportunity to work at one of the world's leading notified bodies, at the heart of medical device regulation.
- Hands-on exposure to EU MDR, EU IVDR, MDSAP and ISO 13485 certification across a wide range of devices and manufacturers.
- An international working environment with daily collaboration across DNV's global Medical Devices network.
- Structured onboarding and continuous learning to build your regulatory and certification expertise.
<Required>
- Bachelor's degree, or equivalent professional experience.
- Fluency in Korean and strong written and spoken English
- Ability to manage multiple projects at once and meet firm deadlines
<Preferred>
- Experience at a notified body, certification body or regulatory consultancy
Auditing experience or knowledge of MDR, MDSAP, and ISO certification schemes
<Personal Qualities>
- Structured, detail-oriented and reliable
- Customer-focused, with clear and confident communication
- A team player who is comfortable working in a global organization
Security and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices.