Regulatory Affairs Executive (Temporary 1 Year)
Olympus Medical Systems Vietnam Co., Ltd.
Job Description
Company: Olympus Medical Systems Vietnam
Hanoi office: V-tower, 649 Kim Ma, Giang Vo, Ha Noi
OLYMPUS MEDICAL SYSTEMS VIETNAM CO., LTD is a subsidiary of OLYMPUS CORPORATION, one of the Japanese leading manufacturers for medical field. Along with our business expansion in Vietnam, we are looking for suitable, qualified candidates for the following positions at our offices in Hanoi.
Job Description
1. Products registration
- Conduct 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.
- Coordinate with vendor or do translation for IFUs from English to Vietnamese with good quality
2. Global/Regional Change Management
- Have proper actions to implement the changes from Global/Regional/Local request, following Vietnamese regulations .
- Prepare and submit the changes to ensure OVN is aligned with Global/Regional/Local actions.
3. System management
- Upload and maintain licenses(for new products, products with changes in license) on SAP
- Upload sub label information on SAP for MD and Non MD products
4. Collaboration with other departments
- Support other departments to ensure registration compliance to meet bidding requirement and to have a smooth importation process.
5. Marketing material reviews
- Conduct review of marketing materials to ensure alignment with registration license
6. Reports & Meeting
- Support the preparation and submisson all external and internal RA reports without delay and mistake
- Support Manager to prepare meeting material for compulsory meetings: MMM, Regional Meeting and etc.
7. Other tasks assigned by Department Manager
- College degree/ bachelor’s degree
- Having 1-2 year or more work experience related to regulatory affairs
- Problem-solving skill
- Communication skill
- Teamwork skill
- Fluently speaking in English (TOEIC650)
- Computer skill (Word, Excel, PPT)
- Responsible, Careful, Detail oriented, Compliant, Logical thinking
Benefits:
- Professional and stable working environment
- Support for petrol allowance, monthly phone costs
- Health Care Insurance Package or Annual Health Checkup
- Team-building activities
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