обновлено 10 дней назад
RA Specialist (Medtech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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