Check with seller Việc làm Hà Nội tuyển gấp Regulatory Affairs Specialist (Invitro Diagnostics) Thành Phố Hà Nội

Mô tả công việc • 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. Quyền lợi được hưởng • Attractive Salary • Health and Other Insurances: as per company policy • Allowance of: Transportation + Meal. Yêu cầu kỹ năng • Minimum Education Required: Degree in Medical science or equivalent • Minimum Experience Required: Min 3 years relevant working experience in INVITRO DIAGNOSTICS (XÉT NGHIỆM CHẨN ĐOÁN)/MEDICAL DEVICES companies • 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

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