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(Senior) Regulatory Affairs Specialist - Medical Device
TM&XNK Vật Tư Giao Thông
45 việc làm
1 lượt xem
Thông tin cơ bản
Mức lương:
Thỏa thuận
Chức vụ:
Nhân viên
Ngày đăng tuyển:
Đang cập nhật
Hạn nộp hồ sơ:
07/01/2025
Hình thức:
Toàn thời gian
Kinh nghiệm:
Không yêu cầu
Số lượng:
1
Giới tính:
Không yêu cầu
Nghề nghiệp
Ngành
Địa điểm làm việc
- Hà Nội
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
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 công việc
• At least College's degree or above (in Medicine/ Pharmacy/ Legal or equivalent) or bachelor's 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.
• 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 được hưởng
Thưởng
13th salary, performance bonus
Chăm sóc sức khoẻ
Personal health insurance
13th salary, performance bonus
Chăm sóc sức khoẻ
Personal health insurance
Khu vực
TM&XNK Vật Tư Giao Thông
Xem trang công ty
Quy mô:
200 - 500 nhân viên
Địa điểm:
Công ty Cổ phần Thương mại và Xuất nhập khẩu Vật tư Giao thông là doanh nghiệp 100% vốn Việt Nam, chuyên về nhập khẩu và cung ứng các sản phẩm nhựa đường, phụ gia, vật tư giao thông. Trải qua hơn hai thập kỷ hình thành và phát triển, hiện công ty là một trong 06 doanh nghiệp hàng đầu thị trường cung ứng các sản phẩm nhựa đường tại Việt Nam. Chúng tôi hiện có trụ sở chính tại Hà Nội với 02 văn phòng đại diện và chi nhánh tại Đà Nẵng và TP. Hồ Chí Minh, 04 tổng kho tại Hải Phòng, Quảng Nam, Khánh Hòa và Đồng Nai.
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