Senior Officer, Ra
6 months ago
$1,300 - $1,500
**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, variations submission.
- Liaise with MOH to ensure products are approved for sales as soon as possible
- Responsible for sub-labeling, advertising, and promotion activities for regulatory compliance
- Responsible for post market surveillance activities i.eComplaint report, FSCA, recall, etc
- Ensure product compliance for tender business.
- Provide regulatory support in tender submission and corresponding inquiry as required
- Assess regulatory needs for pre
- and post-marketing submission
- Input and update global database and system as required
- Deliver the training of processes, procedures, work standards/instruction to internal and external stakeholders and ensure the compliance within delegated function
- Participate in prediction of effect of changes of regulations, policies, or procedure
- Coordinate with other departments i.e. supply chain, business unit to support for product’s availability on the market.
- Responsible for internal and external audits such as audit from suppliers or audit to distributors.
- Assists in any ad hoc tasks as required
**REQUIREMENTS**:
**Technical Skills**
- Native Vietnamese speaker with fluency in English, and superb communication skills both in writing and speaking.
- Commercially astute, eager to partner with business, with strong influencing and interpersonal skills
- Must be able to communicate orally and in written form in concise and articulate manner.
- Strong analytical and problem-solving skills
**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.
- 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.
- Experience managing documentation in English and fluent speaking the language is desired.
**For more information, please contact**:
- Ms. Nguyen Thi Ngoc Ly (84) 24 3936 7618 - Ext: 142
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