Senior Regulatory Affairs Specialist/ Assistant RA Manager - Medical Device

Senior Regulatory Affairs Specialist/ Assistant RA Manager - Medical Device

Địa Điểm Làm Việc: Hà Nội
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13 month salary & Performance bonus
Premium Healthcare for personal & family
Training

Mô Tả Công Việc

JOB SUMMARY:
Responsible for activities which lead to and maintain regulatory approval to market medical devices in Vietnam and/or any assigned market.
Develops and implements regulatory strategies for earliest possible approvals. Ensures timely preparation and submission of technical/regulatory documents to the authorities for product registration. Builds rapport with regulatory agencies. Anticipates regulatory environment change and actively manages the regulatory intelligence for new policy, regulation and requirements.

RESPONSIBILITIES:
Develop registration strategies, prioritizing assignments, implementing regulatory plan and coordinating multiple projects and activities in accordance with latest regulatory requirement and commercial plan.
Manage the regulatory approval or registration of medical devices, license & certificate maintenance to ensure business continuity in Vietnam (and potentially other South East Asia countries) in accordance with applicable local health authorities’ regulations.
Develop and maintain tracking of regulatory status/activity (including prioritization) and ensure the database are kept up to date.
Provide regulatory assessments (e.g. new product development, life-cycle engineering changes/line extensions etc), monitor and manage the necessary regulatory submissions.
Monitor and timely reporting on changes or upcoming changes to medical device laws & regulations affecting registration, distribution and sale & marketing of Abbott products
Cultivation of professional working relationships with local regulatory authorities and local medical device industry association.
Review and approval of A&P materials to ensure compliance with local regulations.
Serve as internal consultant on regulatory requirements such as recalls, advertising and promotional activities or field actions.
Works with internal stakeholders on projects to ensure products meet country import requirements, e.g. labeling
Manages the responsible operational budget effectively
Train other RA team members on Vietnam regulatory requirements as required.

OTHER FUNCTIONS AND RESPONSIBILITIES
Execute the job responsibilities according to applicable standard operating procedures
Perform other related functions and responsibilities assigned by supervisor
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Yêu Cầu Công Việc

QUALIFICATIONS:
Bachelor degree in relevant major.
Minimum 2 years RA experience.
Experience gained in multinational companies, especially in Medical devices is a plus

Địa Điểm Làm Việc

Hà Nội, Vietnam

Abbott believes in the power of health. With better health, people and communities can live better and achieve more.
- We create new solutions - in diagnostics, medical devices, nutrition and branded generic pharmaceuticals - that help people around the world, in all stages of life, live their best lives through better health.
- Founded 125 years ago by Chicago physician Dr. Wallace C. Abbott, Abbott has emerged as one of the largest diversified global health care companies. Our approximately 74,000 colleagues around the globe are devoted to making a lasting impact on human health in the more than 150 countries we serve.
- We believe that good health is not just about treating an illness or managing a medical condition. It’s about supporting people’s health as if it was our own, so they can enjoy all life has to offer. We’ve been focused on helping the people of Vietnam live their best, fullest lives for more than 20 years.

Xem toàn bộ thông tin công ty
02 Ngo Duc Ke, Dist. 1, HCM
1.000-4.999 nhân viên
Talent Acquisition
TUYỂN SINH THẠC SĨ QUẢN TRỊ THƯƠNG MẠI QUỐC TẾ - ĐẠI HỌC NICE SOPHIA ANTIPOLIS (PHÁP)

TUYỂN SINH THẠC SĨ QUẢN TRỊ THƯƠNG MẠI QUỐC TẾ - ĐẠI HỌC NICE SOPHIA ANTIPOLIS (PHÁP)

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