Regulatory Officer

FAS Diagnostics Group Inc; Manila; On-site; PHP 446,000 - 781,000; Full time

Job summary

FAS Diagnostics Group Inc in Manila seeks a Regulatory Affairs and Quality Assurance Officer to coordinate regulatory compliance for diagnostic products, reagents, and medical laboratory equipment. You will maintain quality system documentation and support ISO implementation while ensuring licenses and registrations are current.

You will manage regulatory submissions, liaise with FDA Philippines and other agencies, monitor renewals, review technical documents, and keep a traceable regulatory

Qualifications

• Regulatory affairs, compliance, and documentation responsibilities.
• Familiarity with FDA Philippines regulations for medical devices/IVD preferred.
• ISO 9001:2015 and/or ISO 13485 familiarity preferred; Internal Auditor training a plus.

Responsibilities

• Coordinate regulatory submissions, registrations, permits, and licenses.
• Liaise with FDA Philippines and other regulatory agencies as authorized.
• Monitor renewal dates and regulatory document validity.
• Review product documentation including certificates, labels, and instructions for use.
• Monitor regulatory updates and advise management on compliance.
• Maintain organized regulatory databases and traceability of records.
• Assist in ISO audits, CAPA, and quality management system improvements.
• Support training on ISO, documentation, and quality compliance.

Skills

Regulatory compliance

ISO & QMS awareness

Attention to detail

Analytical & problem-solving

Written & verbal communication

Coordination with agencies & internal

Time management & deadlines

Integrity & confidentiality

Education

Bachelor of Science in Pharmacy

Job description

I. JOB PURPOSE

The Regulatory Affairs and Quality Assurance Officer is responsible for coordinating regulatory compliance, maintaining quality management system documentation, and supporting ISO implementation and compliance activities related to the company's diagnostic products, reagents, and medical laboratory equipment.

The position ensures that applicable regulatory documents, product registrations, licenses, quality records, and internal procedures are properly maintained and updated in accordance with relevant Philippine regulatory requirements and applicable ISO standards.

II. KEY RESPONSIBILITIES

A. Regulatory Affairs and Compliance

1. Prepare, review, process, and monitor applicable regulatory submissions, product registrations, certificates, permits, and licenses required for the company's products and operations.

2. Coordinate with the Food and Drug Administration (FDA) Philippines and other relevant regulatory agencies, as authorized.

3. Monitor the validity and renewal dates of applicable licenses, registrations, permits, and regulatory documents.

4. Review product documentation, including certificates of analysis, product specifications, labels, instructions for use, and other technical documents, as applicable.

5. Monitor regulatory updates affecting diagnostic reagents, IVD products, and medical laboratory equipment, and advise management of relevant compliance requirements.

6. Coordinate with suppliers and manufacturers to obtain the necessary regulatory and technical documentation.

7. Maintain an organized regulatory database and ensure the availability and traceability of regulatory records.

B. ISO and Quality Management System

1. Assist in the implementation, maintenance, and continuous improvement of the company's Quality Management System in accordance with applicable ISO standards.

2. Maintain and update controlled documents, including SOPs, work instructions, quality forms, manuals, and records.

3. Coordinate internal audits, external audits, and follow-up activities for audit findings.

4. Monitor nonconformities, corrective and preventive actions, and the effectiveness of implemented corrective actions.

5. Coordinate with department heads to ensure compliance with approved procedures and quality requirements.

6. Assist in preparing quality reports, audit evidence, and management review documentation.

7. Support employee training and awareness activities related to ISO, documentation, and quality compliance.

C. Product Quality and Technical Documentation

1. Review and maintain applicable product quality and technical documentation received from manufacturers and suppliers.

2. Coordinate with the Technical Application Support, Field Service Engineering, Sales and Marketing, Purchasing, and Warehouse teams on product quality and compliance concerns.

3. Assist in investigating product complaints, quality issues, and reported product deviations.

4. Ensure proper documentation, traceability, and monitoring of quality-related concerns.

5. Coordinate with concerned departments and suppliers regarding product recalls, safety notices, or other corrective actions when applicable.

D. Documentation and Records Management

1. Maintain an updated master list of regulatory documents, licenses, product registrations, and quality records.

2. Monitor document expiry dates, renewal schedules, and submission deadlines.

3. Ensure proper filing, version control, confidentiality, and retrieval of regulatory and quality documents.

4. Prepare periodic reports on regulatory status, pending submissions, renewals, and quality compliance activities.

E. Coordination and Continuous Improvement

1. Work closely with concerned departments to ensure regulatory and quality requirements are incorporated into relevant business processes.

2. Identify compliance gaps and recommend appropriate corrective actions.

3. Provide guidance on regulatory documentation and applicable quality procedures within the scope of the position.

4. Perform other related duties assigned by management consistent with the position and applicable laws.

III. QUALIFICATIONS

1. Bachelor of Science in Pharmacy.

2. Must be a Registered Pharmacist with a valid Professional Regulation Commission (PRC) license.

3. At least two (2) years of relevant experience in Regulatory Affairs, Quality Assurance, ISO compliance, or a related field is preferred.

4. Knowledge of applicable FDA Philippines regulations for medical devices, IVD products, diagnostic reagents, and other regulated products is an advantage.

5. Familiarity with ISO 9001:2015 and/or ISO 13485 is preferred, depending on the company's applicable QMS requirements.

6. ISO Internal Auditor training or certification is an advantage.

7. Experience in medical devices, diagnostic laboratories, pharmaceutical distribution, or healthcare products is preferred.

8. Proficient in document preparation, records management, reporting, and Microsoft Office applications.

IV. REQUIRED COMPETENCIES

• Regulatory compliance and documentation

• ISO and Quality Management System awareness

• Attention to detail and accuracy

• Analytical and problem-solving skills

• Good written and verbal communication

• Coordination with regulatory agencies, suppliers, and internal departments

• Time management and monitoring of compliance deadlines

• Professional integrity and confidentiality

V. KEY PERFORMANCE INDICATORS (KPIs)

1. Timely processing and renewal of applicable regulatory documents.

2. Accuracy and completeness of regulatory submissions and product records.

3. Timely updating of regulatory and quality documentation.

4. Completion of assigned ISO and audit-related activities.

5. Timely monitoring and closure of audit findings and corrective actions.

6. Compliance with applicable regulatory requirements and approved company procedures.

7. Timely submission of regulatory status reports and renewal trackers.