Regulatory Affairs Manager - Medical Devices
Consultant Hanh Bui
Date posted 18 April 2023ha-noi healthcare/regulatory-affairs 2023-04-18 2023-06-17 medical-devices Hanoi Hanoi VN Robert Walters https://www.robertwalters.com.vn https://www.robertwalters.com.vn/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png true
An exciting Regulatory Affairs Manager job has arisen in a medical devices firm in Ho Chi Minh City Vietnam.
About the Regulatory Affairs Manager Role:
Reporting to the Deputy Director, you will be responsible for the submission of all registration types (new, renew, variations, others) as prior plan.
- Understand and share current updates on changes in regulations/guidelines in regulatory affairs in medical devices industry
- Discuss with team to have submission plan in order to ensure submission of all registration types
- Proactively analyse, comment and communicate any changes in the regulatory environment to RA and related teams
- Coordinate with manufacture, region and prepare dossier for product registration (medical devices equipment and consumables) following the regulation
- Supervise the registration of marketed product
- Evaluate and review registration dossiers for administration
- Keep track of registration status, submissions and registration timeline
- Effectively manage and accelerate registration approval
- Identify decision makers and develop appropriate stakeholder's mapping/solution, in collaboration with related team members or others
- Create mid-term action plan with our original value based on the direction from HQ and GD to achieve such direction
- Review and arrange the submission document to local authority to support exhibition and workshop organised by marketing team
To succeed in this role, you will need to have at least three to five years' experience in regulatory affairs at medical devices companies.
- Three to five years' experience in relevant position, registration of medical devices product
- Medical devices industry in Vietnam regulations on registration
- Advanced management skill
- Logical thinking skill
- Problem solving skill
- Presentation skill
- Target management skill
- Fluently speaking in English
- Computer’s skill (Word, Excel, PPT)
This leading medical devices firm needs no further introduction and great value is placed on training and development.
If you are driven, this is the role for you.
Apply now or call me to discuss this new opportunity.
Due to the high volume of applications we are experiencing, our team will only be in touch with you if your application is shortlisted.
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