Regulatory Affairs

**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
- 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, compliancetest requirements, potential regulatory pathways, or clarification, and follow-up on submissions and reviews quality management systemo 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 Management 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.
- Prepare for internal and external audits and ensure successful outcomes, tackle audit findings and recommendations in a timely manner
- Follow-up and verify corrective/preventive action (CAPA) effectiveness.
- Provide ISO 9001 and GDPMDS orientation to new employees

**3. Compliance**
- Coordinate, schedule and conduct required compliance orientation and training for employees
- Responsible to ensure compliance to regulations related to export controls and maintain records
- 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.

**REQUIREMENTS**
- A Degree in Life Sciences, Biomedical or any other related discipline.
- Minimum 2 years’ experience in performing a similar job scope.
- Relevant experience in regulatory affairs will be advantageous
- Able to work under a matrix reporting structure.
- Good organizational and time management skills.
- A strong database experience (Access, Excel) to set up functions, enter data or process information.
- Excellent interpersonal, presentation and verbal/written communications skills.
- Meticulous, able to work independently and timely in meeting deadlines.
- Integrity with a history of ethical decision-making is essential
- Sound knowledge of the regulatory requirements and legal framework for products and industry trends in the Asian Region.
- Knowledge in GDPMD, ISO9001, IVDR preferred.
- Familiarity with Health Science Authority’s regulatory on medical devices, product registration, field safety correction and licensing requirements.