Senior Regulatory Affairs Specialist - Invitro Diagnostics - Medical Devices (or Team Leader/ Supervisor)

Senior Regulatory Affairs Specialist - Invitro Diagnostics - Medical Devices (or Team Leader/ Supervisor)

Job Locations: Ha Noi
Negotiable 412 views - Expires in 3 days

What We Can Offer

Attractive Salary
Health and Other Insurances: as per company policy
Allowance of: Transportation + Meal

Job Description

Key Job Purpose :
• Dossier preparation & product registration submission to Vietnam Ministry of Health (MOH), leading to timely introduction of new products and responsible for supplemental filings for any changes.
• Assisting in data/information gathering & dossier compilation for product registration submission & other related licenses for distributors including progress monitoring & follow-ups.
• Provide regulatory support, update, advisory & knowledge sharing to other departments, distributors and Sysmex Asia Pacific in order to remain in compliance with the government regulatory requirements in Vietnam.
• Support for all legal compliance matters.
• Serve as the primary contact between the company and regulatory agency-MOH. Maintain and develop relationship with MOH and relevant organization.

Summary of Functional Duties & Responsibilities:
1. Contact to Sysmex Asia Pacific regulatory affair department to get necessary documents for Sysmex Vietnam and distributors.
2. Prepare & submit product registration documentation & other relevant licenses’ application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration in Vietnam.
3. Notify and update MOH of any change of particulars/documents related to product registration.
4. Ensure changes to the approved products are timely submitted to MOH as required.
5. Manage adverse event and field safety corrective action reporting to MOH within stipulated timeline.
6. Maintain product approvals and dealer’s licenses.
7. Maintain product registration record and product registration database to ensure proper documentation and record filing.
8. Serve as the primary contact between the company and regulatory agency-MOH. Maintain and develop relationship with MOH and relevant organization.
9. Maintain the knowledge and awareness of current applicable regulations and standards.
10. Support business partners in new product registration, renewals and amendments.
11. Support other departments in all regulatory related areas, legal compliance matters.
12. Responsible for registering, adjusting Business Registration Certification.
13. Manage sub-label and the dressing instructions.
14. Manage translation of registration document as package insert, operation manual,…
15. Read, update and follow company's standard operating procedures and guidelines in daily work.
16. Support Managers/Supervisor to make, review and improved standard operating procedures and guidelines.
17. Join meeting & training according to Manager/ Supervisor’s instruction.

Authorize :
• To use of equipment and facilities of the Company to serve the purpose to complete the task.
• To enjoy the full benefits stipulated in the labor agreement and labor law.
• To refuse to perform the tasks assigned by Manager/ Superiors which not in conformity with the law.
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Job Requirements

This position is open to be upgraded to higher level (MANAGER) depending on candidate's experience.

Job Specification :
- Minimum Education Required: Degree in Medical science or equivalent
- Minimum Experience Required: Min 5 years relevant working experience
- Skills and Knowledge Required: PC literate, Good English in Speaking, Reading, Translation, Good communication.
- Attitude Required: Hardworking and careful, positive mindset of customer satisfaction, teamwork and compliance
- Knowledge Desired but not Essential: Biomedical or Healthcare
- Travel Requirement: Flexible to respond to company request for company, regional training/meeting

Job Locations

Vinaconex Building, 34 Lang Ha, Dong Da District, Hanoi, Vietnam

Sysmex Vietnam is a subsidiary company of Sysmex Asia Pacific Pte Ltd., the Asia Pacific regional headquarters of Sysmex Corporation.

Established in 2010, Sysmex Vietnam markets a comprehensive range of state-of-art clinical diagnostic technology and health IT solutions. Sysmex delivers total solutions in the field of clinical laboratory testing, including hematology and urinalysis. In the core field of hematology, Sysmex is the global market leader, occupying the number-one share of the worldwide market, also of coagulation instrumentation worldwide.

Sysmex Vietnam is a very active, friendly and supportive team. We are calling all professionals joining. Submit your CV now and let us kick-start your Career.

Website: www.sysmex.com.vn

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Floor 8, Unit 802 CentrePoint Building 106 Nguyen Van Troi Str., Phu Nhuan Dist., Ho Chi Minh City
25-99 staffs
CHƯƠNG TRÌNH THẠC SỸ TÀI CHÍNH QUỐC TẾ | ĐẠI HỌC J.M.LYON 3 (PHÁP) | VIỆN ĐÀO TẠO QUỐC TẾ - ĐẠI HỌC THƯƠNG MẠI

CHƯƠNG TRÌNH THẠC SỸ TÀI CHÍNH QUỐC TẾ | ĐẠI HỌC J.M.LYON 3 (PHÁP) | VIỆN ĐÀO TẠO QUỐC TẾ - ĐẠI HỌC THƯƠNG MẠI

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