Senior Regulatory Affairs & Quality Assurance Specialist - Medical Devices

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☞ PERSOLKELLY Vietnam

视图: 206

更新日: 14-04-2024

位置: Ha Noi

类别: 保健/医疗 制药/化学/生物技术

水平: Nhân viên

薪水: Cạnh tranh

水平: Đại học

经验: 3 - 6 Năm

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职位描述

JOB OVERVIEW

The Senior Regulatory Affairs & Quality Assurance Officer 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, FSCA, Recall, etc.

Key duties & responsibilities:

  • Responsible for implementing and managing the regulatory activities of medical devices in accordance with MOH 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, 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, work standards/instruction to internal and external stakeholders and ensure compliance within the delegated function
  • Participate in the prediction of the effect of changes of regulations, policies, or procedure
  • Coordinate with other departments i.e., supply chain, and business unit to support for 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

工作要求

EDUCATION AND EXPERIENCE

  • A Bachelor of Science Degree with at least 3-5 years’ experience in Quality Assurance and Regulatory Affairs in MNC for Medical Devices or Pharma industry.
  • Native Vietnamese speaker with fluency in English and superb communication skills in writing and 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

工作兴趣

  • Chế độ bảo hiểm
  • Du Lịch
  • Phụ cấp
  • Chế độ thưởng
  • Chăm sóc sức khỏe
  • Đào tạo
  • Tăng lương
  • Công tác phí
  • Nghỉ phép năm
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最后期限: 14-05-2024

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