Thông Tin Tuyển Dụng
98303 - Senior Regulatory Affairs and QA Specialist - Medical Equipment
|Cấp bậc||Nhân viên|
|Lương||$ Cạnh tranh|
|Hết hạn nộp||06/12/2023|
|Ngành nghề||Sản xuất / Vận hành sản xuất|
|Kinh nghiệm||3 - 5 Năm|
- Working location: Dong Da District, Hanoi.
<Position Objective/Expectation >
The Senior RA and QA Specialist, who will be responsible for obtaining medical device pre-market regulatory approval to ensure market access is realized for product portfolio and service in the Vietnam market. Senior Officer RA/QA also will handle the sub-labeling, advertisement regulatory activities, and post-marketing regulatory activities i.e. complaint report,...
• Responsible for implementing and managing the regulatory activities of medical devices by MOH (Ministry Of Health) registration guidelines including new product submission, renewal submission, classification certificate, and variations submission.
• Liaise with MOH to ensure products are approved for sale as soon as possible
• Responsible for sub-labeling, advertising, and promotion activities for regulatory compliance
• Responsible for post-market surveillance activities i.e.… Complaint report, FSCA (Financial Sector Conduct Authority), recall, etc.…
• Ensure product compliance for tender business.
• Responsible for database, processes, and systems to manage and maintain all regulatory documents needed for regulatory, tender application, and sales
• Provide regulatory support in tender submission and corresponding inquiry as required
• Assess regulatory needs for pre- and post-marketing submission
• Input and update the global database and system as required
• Deliver the training of processes, procedures, and work standards/instruction to internal and external stakeholders and ensure the compliance within delegated function
• Participate in the prediction of the effect of changes in regulations, policies, or procedure
• Coordinate with other departments i.e. supply chain, and business unit to support product availability on the market.
• Responsible for internal and external audits such as audits from suppliers or audits to distributors.
• Assists in any ad hoc tasks as required
・Age: 25 ~ 35
・Education: Bachelor's Degree
・Language: English - Business Level
- At least 3 years of experience in Quality Assurance and Regulatory Affairs in MNC for Medical Devices or Pharma industry.
- Experience managing documentation in English and fluent English speaking
- Good working knowledge of the following software programs: Microsoft Word, Excel, PowerPoint, and Outlook.
- Proofed experience performing internal/external audits.
- Writing standard operating procedures and work instructions.
Only shortlisted candidates will be approached by RGF's consultant. Your resumes will be recorded in our system, and you will receive our Job Introduction Auto-email with suitable jobs in the coming time. Please check your email regularly to get our vacant job. Thanks so much!
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