RA & QA Manager - Healthcare

Location:
Hanoi
All
Work Type:
Permanent
Salary:
to
Location: Hanoi
Salary: Negotiable
Industry: Medical Devices
An opportunity in RA & QA has just come from a multinational company in Medical Devices. This position will have 2 subordinates in Hanoi Office and report directly to General Director.
JOB OVERVIEW:
Report to General Director
Subordinate: 2 RA & QA Specialists
Job Location: Hanoi
JOB DESCRIPTION:
1. General Management:
Understand and penetrate company's 5 Core Values: Integrity, Empathy, Long-term view, Agility, Unity into daily activity. Nurture junior managers and next generation who have Core Value in mind.
Create Mid-term action plan with our original value based on the direction from HQ and manage to achieve such direction.
Conduct performance appraisal for subordinates and make a consensus in the Department through the MBO every half year
2. Regulatory Operations:
Products registration
Manage product registration activities including drafting, reviewing, compiling, and maintaining all necessary registration documentation for submissions according to local regulations.
Ensure submissions are executed, monitored and accomplished for market clearance in a timely manner.
Ensure the new registration certificates are approved and issued
Import licenses
Review all process and document related to import license.
Ensure the license, submitted dossiers and overall process and procedure are complied with current regulations
Complaints Handling:
Handle and take follow-up actions for all complaints from customers about the products quality until the closure.
Ensure the safety for users and patients, the compliance with local regulation for traceability and post market surveillance, and the process and procedure followed by the directions from Global Team.
FSCA / Recall
Take the proper actions of remedial measures for affected products, including: repairing, recalling or replacing the products.
Ensure the safety for users and patients, the compliance with local regulation for traceability and post market surveillance, and the process and procedure followed by the directions from Global Team.
Regulation update:
Monitor impact of changing regulations on submission strategies and update to upper management. Compile, prepare, review and submit regulatory submission to related authorities (Ministry of Health, Hanoi Department of Health, Ministry of Trade and Industry and other authorities if required)
Evaluate regulatory risks for Medical division, and formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Temporary import license for Exhibition / Workshop
Review and arrange the submission document to local authority to support exhibition and workshop organized by Marketing team.
Ensure the license, submitted dossiers and overall process and procedure are complied with the local regulation for temporary import activities.
Cooperating with other departments in company
Ensure updates of proper documentation as requested by Sales/MKT/SCM and provide administrative support to departments for smooth business operation.
Quality Management System:
Create SOPs for QMS. QMS includes SOPs for Complaint Handling procedure / Adverse Event reporting / Training / FSCA / Documents Control / Management review / CAPA / Quality Policy / Internal Audit. Following by the directions from Global Team for QMS of each S-BC
3. Training:
Based on company's policy of HR development, make plan and conduct staff education and manage subordinates' skill level.
JOB REQUIREMENT:
Bachelor's degree in relevant fields
Knowledge in Regulatory affairs on medical devices & Management.
More than 2 years experience as a RA/QA Manager
Job Instruction and Coaching skill
Time management skill
Communication skill
Basic management skill
Fluency in English
#LI-PSKVN
Reference Number:
556389
Contact Details:
Ms. Trang
Profession:
Healthcare > Medical devices
Company:
A Multinational Firm in Medical Devices