Quality and Regulatory Affairs (QARA) Officer

Job description:

The Quality and Regulatory Affairs (QARA) Officer will provide leadership in the quality and regulatory affairs function, ensuring compliance with regulatory requirements for the importation and distribution of products. The role involves authoring and refining process documentation and maintaining and monitoring the company’s quality management system.

1. Quality Assurance (QA)

• Develop, implement, and maintain the company’s quality management system (QMS) in accordance with applicable standards and regulations.
• Conduct internal audits to ensure compliance with standard operating procedures (SOPs) and company policies.

1. Regulatory Affairs (RA)

• Prepare, review, and submit regulatory documents and product registration applications to relevant authorities (e.g., FDA, PDEA, BOC).

1. Documentation and Compliance

• Maintain accurate and organized documentation related to quality and regulatory affairs.
• Ensure product labels, packaging, and marketing materials comply with regulatory requirements.

1. Cross-Functional Collaboration

• Work closely with the Sales & Marketing, and Technical Group to provide regulatory support and ensure product compliance.

• Graduates in the field of health profession such as Pharmacy, Nursing, Medical Technology, Dentistry, Radiology Technology, Medicine, Physical Therapy, and other allied science courses relevant to the device to be distributed
• Certification or training in Quality Management Systems (QMS), Good Warehousing Practices (GWP), or regulatory affairs
• PRC License
• Knowledge of local and international regulations (e.g., FDA, ISO 9001, ISO 13485, GWP, GDP).

Job Types: Full-time, Permanent

Benefits:

• Company Christmas gift
• Company events
• Health insurance
• Opportunities for promotion
• Paid training

Education:

• Bachelor's (Preferred)

License/Certification:

• PRC ID (Required)