Dentsply Sirona
Dentsply Sirona
Dentsply Sirona бүкіл әлемде ауыз қуысының денсаулығын жақсартуға ұмтылатын мамандарға арналған стоматологиялық шешімдерді әзірлейді және өндіреді. Компания 50-ден астам елдегі стоматологиялық тәжірибелерді қолдау үшін зерттеулерді, өнім әзірлеуді және өндірісті біріктіреді. Оның командалары сату, жеткізу тізбегі және корпоративтік операциялар сияқты бағыттарға үлес қосып, бүгінгі және ұзақ мерзімді перспективадағы стоматологияны дамытуға назар аударады.

Regulatory Affairs Manager - Seoul, South Korea

Lead medical-device registrations, labeling, regulatory strategy, and related quality activities for Dentsply Sirona Korea. The role supports dental products and technologies in an onsite Seoul position.

Сипаттама

  • Build, maintain, and enhance regulatory affairs processes for Dentsply Sirona Korea
  • Ensure Korean operations comply with corporate policies and Korean medical-device regulations
  • Provide oversight of quality assurance activities for up to 10% of the role
  • Manage and collaborate with Korea-based regulatory affairs personnel
  • Oversee product registrations, including existing registration maintenance and timely registration of new products
  • Report registration status and related data to Product Groups, functional teams, and management
  • Define and communicate pre-submission strategies and potential regulatory pathways
  • Clarify submission requirements and follow up on applications under review
  • Track regulatory intelligence and evaluate changes in the regulatory environment
  • Prepare regulatory scenarios and impact assessments to support management decisions
  • Build professional relationships with regulatory authorities, legislators, trade associations, and key opinion leaders
  • Oversee Korean labels, labeling, IFUs or manuals, UDI, and symbols to maintain regulatory compliance
  • Prepare and present budgets for regulatory activities
  • Track spending in line with internal policies and external requirements
  • Maintain comprehensive knowledge of Dentsply Sirona products and systems
  • Lead, develop, coach, and retain regulatory affairs talent
  • Promote strategic thinking, problem solving, accountability, customer focus, innovation, and change management

Талаптар

  • Bachelor’s degree or higher; a scientific, engineering, or healthcare background is preferred
  • At least 8–10 years of experience in medical-device regulatory and quality work
  • Three to five years of team management experience
  • Experience working with cross-cultural teams is preferred
  • Excellent written and verbal English communication skills
  • Strong interpersonal, stakeholder-influencing, and relationship-building skills
  • Project management capability
  • High attention to detail
  • Ability to perform under pressure and meet tight deadlines
  • Logical reasoning, sound judgment, and open communication
  • Eligibility to work in the country where the position is based

Артықшылықтар

  • Dentsply Sirona is an equal opportunity employer
  • Work authorization eligibility support is available to successful applicants who are eligible to work in South Korea
  • Assistance with disability accommodations is available when completing the online application

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