Job Description
<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
Job Requirement
<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.