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RA Specialist (Medtech)

Формат работы
remote (только South_korea)/onsite/hybrid
Тип работы
project
Грейд
junior/middle
Английский
b2
Страна
SK
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
RA Specialist (Medtech): Managing regulatory affairs projects and strategic planning to mitigate regulatory risks for medical devices with an accent on product life cycle management and post-approval change controls. Focus on ensuring compliance with Korean and international regulations and conducting business impact analysis of regulatory changes.

Location: Onsite in Seoul, South Korea (Hybrid/remote work options available per company policy)

Company

hirify.global is a global leader in the medical devices industry dedicated to protecting and improving the health of people worldwide.

What you will do

  • Manage RA projects and develop short-to-mid-term plans aligned with company strategy.
  • Handle product life cycle management and post-approval change controls to mitigate risks.
  • Ensure timely completion of product registrations and line extensions.
  • Maintain collaborative relationships with internal stakeholders, CoE GRA, and external regulatory bodies.
  • Monitor regulatory environment changes and perform business impact analyses.
  • Manage budgets for assigned regulatory projects.

Requirements

  • Must be based in or able to work in Seoul, South Korea.
  • 1–5 years of relevant experience in the medical device industry (interns are welcomed).
  • Sound knowledge of Korean and international medical device regulations.
  • Good command of spoken and written English.
  • Effective communication, problem-solving, and decision-making skills.
  • Experience in multinational companies or project leadership is preferred.

Culture & Benefits

  • Competitive benefits within the healthcare industry.
  • Flexible working hours, early leave system, and remote work options.
  • Flexible benefit allowance provided via a welfare card.
  • Communication expense support and birthday vouchers.
  • Comprehensive health screenings, family event grants, and paid leave.
  • Tuition support for children in high school and university.
  • Recognition for long-term service.

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