Regulatory Affairs Specialist

Dentsply Sirona

. Ensure timely registration of new products and maintenance of existing product licenses .

Posted 10/13/2026full-timeSeoul • South KoreaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for medical devices, ensuring compliance with MFDS and corporate requirements while managing product registrations and licenses. Proficient in supporting audits, labeling reviews, and adapting to regulatory changes in a fast-paced environment.

Highest-signal resume keywords

Regulatory Affairs ExperienceKGMP ComplianceProduct License ManagementFluent in EnglishProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ActivitiesProduct RegistrationLicense MaintenanceLabeling ReviewAnnual ReportingUDI ManagementCompliance ManagementProject ManagementAudit SupportRegulatory Environment Analysis

Soft Skills

Interpersonal SkillsTeam CollaborationResponsibilityTask ManagementAdaptability

Tools & Technologies

UDI Database

Industry Keywords

MFDSKGMPMedical DevicesRegulatory ComplianceProduct RenewalsPromotional Material ReviewExplanatory ConferencesLocal-Language LabelingEthical RequirementsCorporate Requirements

About the role

Key responsibilities & impact

Ensure timely registration of new products and maintenance of existing product licenses
Ensure compliance with MFDS and corporate requirements
Support internal and external KGMP audits and inspections as company representative
Manage assigned new registration and existing product-license maintenance projects
Anticipate regulatory environment changes and take appropriate action
Support KGMP certificates, labeling, approval variations, annual reporting, and product renewals
Comply with legal, regulatory, ethical, local, and corporate requirements
Develop and lead local-language labeling and promotional-material reviews
Participate in industry meetings and MFDS explanatory conferences and share information with teams and departments
Support internal tasks assigned by the line manager
Work with UDI, including the UDI database

Requirements

What you’ll need

University/Bachelor’s Degree and major in science or engineering preferred
More than 3 years’ experience in regulatory affairs of medical devices
Specialized knowledge of regulatory activities
Experience with KGMP is favoured
Fluent in English
Ability to manage multiple and varied tasks in a fast-moving environment
Strong sense of responsibility for meeting due/target dates
Good interpersonal skills and proven ability to contribute to a team environment
No reason for disqualification for overseas travel
Must be eligible to work in the country where the position is based