Senior Regulatory Affairs and QA Specialist - Medical Equipment

<Job Responsibilities>
• 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

<Necessary Skill / Experience >
・Education: Bachelor's Degree
・Language: English - Business Level
・Experience:
- 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
・Others:
- 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.

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