Dentsply Sirona razvija in izdeluje zobozdravstvene rešitve za strokovnjake, ki si po vsem svetu prizadevajo izboljšati ustno zdravje. Podjetje združuje raziskave, razvoj izdelkov in proizvodnjo ter tako podpira zobozdravstvene ordinacije v več kot 50 državah. Njegove ekipe prispevajo na področjih, kot so prodaja, dobavna veriga in korporativno poslovanje, pri čemer se osredotočajo na napredek zobozdravstva danes in dolgoročno.
Regulatory Affairs Specialist, Dental Devices
Manage South Korean regulatory submissions and product licenses for Dentsply Sirona’s dental devices, including MFDS registration, KGMP compliance, labeling, and UDI. The Seoul-based role supports audits, renewals, and regulatory updates.
Opis
- Coordinate timely registration of new products and renewals of existing licenses.
- Maintain compliance with MFDS rules and company policies.
- Represent the company in internal and external KGMP audits and inspections.
- Manage assigned product registration and license maintenance projects.
- Monitor regulatory changes and respond with appropriate actions.
- Support KGMP certificates, labeling, approval changes, annual reports, and product renewals.
- Follow applicable legal, regulatory, ethical, local, and corporate requirements.
- Lead reviews of local-language labels and promotional materials.
- Attend industry meetings and MFDS information sessions, sharing updates with relevant teams and departments.
- Handle additional internal assignments from the line manager.
- Support UDI activities, including management of the UDI database.
Zahteve
- A bachelor’s degree, preferably in science or engineering.
- More than three years of medical-device regulatory affairs experience.
- Specialized knowledge of regulatory activities.
- KGMP experience is preferred.
- Fluent English.
- Able to manage varied, concurrent tasks in a fast-paced environment.
- Strong accountability for meeting deadlines and target dates.
- Good interpersonal skills and a demonstrated ability to work effectively in a team.
- No restrictions that would disqualify you from overseas travel.
- Eligible to work in the country where the position is based.