1. Regulatory Affairs
   Understand relevant regulatory regulations, policies & procedures behind the company’s business activities and products.
   Ensure product and company’s compliance with regulations for maintenance of approvals.
   Maintain ISO and GDPMDS records and work closely with the ISO/GDPMDS team to provide timely updates on company’s regulatory and licensing matters.
   Preparation and submission of regulatory applications, including creating and maintaining templates and ensuring completion of submissions.
   Advise management on regulatory processes, compliance, and updates to policies.
   Responsible for the maintenance of regulatory documentation databases.
   Develop and maintain communication with regulatory agencies regarding submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions and reviews.
   Liaise with relevant regulatory body regarding pre-marketing applications related to new product(s) launch in local and/or regional markets
   Main contact point for various regulatory-related internal inquiries regarding logistics, pre/post-marketing events in addressing customers’ requirements.
   Support the country managers in medical device regulations or other regulations for regional countries.
   Liaise with related departments in the PHC Group.
   2.Quality Managment System
   Support the Management Representative in the company quality management system.
   Maintain and update the document control system to ensure all quality-related documents are easily accessible, properly categorized, and up to date.
   Oversee the implementation and maintenance of Quality Management Systems (QMS) in accordance with ISO9001, GDPMDS and other relevant standards.
   Review and update ISO 9001 & GDPMDS documents when necessary and maintain records.
   Review and ensure all documents, including SOPs, work instructions, manuals, and forms, meet regulatory and company standards.
   Handle quality related matters such as non-conformances, customer complaints, change notification.
   Handle customer or supplier related enquiries, questionnaire and etc.
   Handle customer audit
   Support internal and external audits and inspections to ensure compliance with regulations and standards. Prepare reports and action plans for any non-compliance issues.
   Follow-up and verify corrective/preventive action (CAPA) effectiveness.
   Provide ISO 9001 and GDPMDS orientation to new employees
2. Compliance
   Support the Compliance Manager in implementing PHC’s compliance program and policies.
   Coordinate, schedule, and conduct required compliance orientation and training for employees
   Responsible to ensure compliance to regulations related to export controls and maintain the records
   Manage the contracts database and business licenses, including reviewing contracts and liaising with the PHC Group legal team.
   Provide support to employees on regulatory requirement and compliance procedures.
   Serve as a BizSafe member by overseeing and coordinating the preparation, management, and maintenance of all risk management and related documentation. Ensure all required documents are completed, up-to-date, and in compliance with BizSafe standards and regulations

Please refer the Job description for details