Regulatory Affairs Specialist (Invitro Diagnostics) - Temporary 12 Months

Key Job Purpose :
• Serve as the primary contact between the company and regulatory agency-MOH. Maintain and develop relationship with MOH and relevant organization.
• 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.
• 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.
Summary of Functional Duties & Responsibilities:
Manage translation of registration document as package insert, operation manual,…
Support other departments in all regulatory related areas, legal compliance matters.
Serve as the primary contact between the company and regulatory agency-MOH. Maintain and develop relationship with MOH and relevant organization.
Notify and update MOH of any change of particulars/documents related to product registration.
Support Managers/Supervisor to make, review and improved standard operating procedures and guidelines.
Maintain product registration record and product registration database to ensure proper documentation and record filing.
Maintain the knowledge and awareness of current applicable regulations and standards.
Manage sub-label and the dressing instructions.
Ensure changes to the approved products are timely submitted to MOH as required.
Contact to Sysmex Asia Pacific regulatory affair department to get necessary documents for Sysmex Vietnam and distributors.
Read, update and follow company&039;s standard operating procedures and guidelines in daily work.
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.

• Knowledge Desired but not Essential: Biomedical or Healthcare
• Minimum Education Required: Degree in Medical science or equivalent
• Attitude Required: Hardworking and careful, positive mindset of customer satisfaction, teamwork and compliance
• Minimum Experience Required: Min 3 years relevant working experience in INVITRO DIAGNOSTICS (XÉT NGHIỆM CHẨN ĐOÁN)/MEDICAL DEVICES companies
• Travel Requirement: Flexible to respond to company request for company, regional training/meeting
• Skills and Knowledge Required: PC literate, Good English in Speaking, Reading, Translation, Good communication.

Attractive Salary

Health and Other Insurances: as per company policy

Allowance of: Transportation + Meal

Cập nhật gần nhất lúc: 2022-01-13 11:02:02