Dentsply Sirona dezvoltă și produce soluții stomatologice pentru profesioniștii care lucrează la îmbunătățirea sănătății orale în întreaga lume. Compania combină cercetarea, dezvoltarea produselor și producția pentru a sprijini cabinetele stomatologice din peste 50 de țări. Echipele sale contribuie în domenii precum vânzările, lanțul de aprovizionare și operațiunile corporative, concentrându-se pe progresul stomatologiei în prezent și pe termen lung.
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.
Descriere
- 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.
Cerințe
- 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.