Regulatory Affairs

Roles & Responsibilities

Principal Task: The successful candidate will first and foremost be responsible for regulatory affairs and product registrations for all SciMed products. The candidate will be the focal point of contact for advice on regulatory guidelines and activities. Besides regulatory affairs, the candidate will also support the Management Representative in ensuring an effective Quality Management System (QMS) and local implementation of PHC's compliance policies and ensure full adherence where necessary.

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, 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

Candidates should bring with them

• 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
• Good knowledge and application of Microsoft 365.
• 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.

Tell employers what skills you have

Licensing
CAPA
Quality Management
Quality Management Systems
Regulatory Affairs
ISO
Risk Management
Compliance
Medical Devices
Audits
Regulatory Requirements
Life Sciences
Audit

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