Check with seller Tuyển dụng Hà Nội FUJIFILM cần tuyển

[Tuyển dụng Hà Nội] FUJIFILM cần tuyển Chi tiết công việc

Giới thiệu công ty



Thu nhập:
Thỏa thuận
Loại hình:
Toàn thời gian





Chức vụ:
Nhân viên





Kinh nghiệm:
1 - 3 năm
distribution
product development
etc
compliance
Mô tả công việc
• Responsible for implementing and managing the regulatory activities of medical devices
following MOH (Ministry of Health) registration guidelines, including new product
submission, renewal submission, and variations
• Maintain data in information systems or databases. Have responsibility in following up &
making new or renewed registration for all company products, following up expiry of
FSC, EC & ISO to update timely & distribution authorization term...)
• Liaising and negotiating with regulatory authorities and providing advice about
regulations to principals and company. Responsible for all communication and follow-up
with the Ministry of Health to ensure a smooth and fast registration process.
• Keep manufacturer on update with any feedback from authorities and deal with facility or
regional team for their support to accelerate approval of Ministry of Health.
• Provide regulatory assessments (e.g. new product development, life-cycle engineering
changes/ line extension etc.), monitor and manage the necessary regulatory
submissions.
• Provide regulatory support in tender submission and corresponding inquiry as required.
Advice and supporting business, marketing and others team in regulatory.
• Ensuring the awareness on obligations to comply with regulatory requirements and other
applicable statutory requirements and any decision thereof made by top management
throughout the establishment and supply chain.
• Keeping up to date with changes in regulatory legislation and guidelines. Monitor and
timely reporting on changes or upcoming changes to medical device laws and
regulations affecting registration, distribution and sale & marketing team.
• Review and approval of relevant documents/materials to ensure compliance with local
regulations. Outlining requirements for labelling, storage and packaging, and approving
information leaflets and labels.
• Any other duties and responsibilities as and when assigned by Line Manager
Yêu cầu
• At least Colleges degree or above (in Medicine/ Pharmacy/ Legal or equivalent) or bachelors degree with related experiences.
• Minimum 1-3 years of experience or in the same position (prefer in medical device industry).
• Good experience and knowledge in medical equipment and consumables in Healthcare Industry.
• Good English or other language in both spoken and written.
• Proficiency in MS Word, MS Excel and MS Outlook.
• Displaying strong detailed knowledge of the product/service that you are involved in;
• Strong organizational skills and take initiative.
• Attention to detail and the ability to maintain confidentiality of product registration documents.
• Strong administration and organizational skills
• Teamwork
• Analytical skills
• Multi-tasking management
• Proactive and solutions finder
• Good communication in Vietnamese and English
• Having good relationship with authorities is an advantage.
Quyền lợi
Thưởng
13th salary, performance bonus
Chăm sóc sức khoẻ
Personal health insurance
Thông tin khác
Địa điểm làm việc
- Hà Nội
Việc làm Hà Nội
Thông tin chung
Thu nhập: Thỏa thuận
Cách thức ứng tuyển
Ứng viên nộp hồ sơ trực tuyến bằng cách bấm nút
Ứng tuyển
bên dưới:
Tags:Tuyển dụng Hà Nội, việc làm Hà Nội, FUJIFILM tuyển nhân viên

Contact seller Share

Comments