Regulatory Affairs Officer

Medtecs International Corporation Limited; Makati; On-site; PHP 540,000 - 720,000; Full time

Job summary

Medtecs International Corporation Limited in Makati City seeks a licensed Pharmacist to manage regulatory affairs for importation, registration, and distribution of medical devices and other regulated products, ensuring compliance with Philippine FDA regulations. You will coordinate FDA submissions, licenses, permits, and registrations, maintain regulatory records, and liaise with HQ and overseas offices.

The role requires at least 1 year in regulatory affairs, strong documentation skills, and

Qualifications

• Licensed Pharmacist in the Philippines and at least 1 year in Regulatory Affairs.
• Experience with FDA applications, licenses, permits, and regulatory documentation preferred.
• Strong documentation, monitoring, and records-management skills.

Responsibilities

• Manage and monitor regulatory requirements for importation, exportation, registration, and distribution of medical devices and other regulated products.
• Ensure compliance with Philippine FDA regulations, licensing requirements, and applicable regulatory standards.
• Process, monitor, and maintain FDA applications, licenses, permits, certificates, and product registrations (LTO, CMDN/CMDR, etc.).
• Maintain regulatory records and ensure timely filing, renewal, and completion of licenses, registrations, and permits.
• Coordinate documentary requirements for FDA applications across Medtecs affiliates and with HQ in Taiwan and overseas offices.
• Coordinate with external regulatory consultants and consultant pharmacists supporting Medtecs.
• Review regulatory documents for completeness, accuracy, validity, and compliance prior to submission.
• Provide weekly regulatory status reports to management.
• Monitor regulatory developments and advise management of changes affecting products, licenses, or operations.

Skills

Regulatory affairs

Documentation

Communication

Regulatory submissions

Education

Pharmacist license (Philippines)

Tools

Microsoft Office

Job description

About the role

Manage and monitor regulatory requirements for the importation, exportation, registration, and distribution of medical devices and other regulated products. Ensure compliance with current Philippine Food and Drug Administration (FDA) regulations, licensing requirements, and applicable regulatory standards.

Key responsibilities

• Manage and monitor regulatory requirements for the importation, exportation, registration, and distribution of medical devices and other regulated products.

• Ensure compliance with current Philippine Food and Drug Administration (FDA) regulations, licensing requirements, and applicable regulatory standards.

• Process, monitor, and maintain FDA applications, licenses, permits, certificates, and product registrations, including License to Operate (LTO), Certificates of Medical Device Notification/Registration (CMDN/CMDR), and other applicable regulatory requirements.

• Maintain an updated regulatory tracker and ensure timely filing, renewal, and completion of all licenses, registrations, certificates, and permits.

• Coordinate and consolidate documentary requirements for FDA applications of Medtecs-affiliated companies, including:

  • Medtex Corporation
  • Medtrends Distributors Corporation
  • U-Net Distributors Corporation

• Coordinate with HQ Taiwan, Cambodia, manufacturers, suppliers, and other relevant parties to obtain technical and regulatory documents required for FDA submissions.

• Coordinate with and monitor external regulatory consultants and consultant pharmacists supporting Medtecs and its affiliated companies.

• Review regulatory documents for completeness, accuracy, validity, and compliance before submission to government agencies.

• Maintain complete and properly organized regulatory records, including applications, approvals, certificates, licenses, permits, correspondence, and supporting documents.

• Facilitate document authentication, legalization, or certification with relevant government agencies and foreign representative offices, when required.

• Process applicable certifications and regulatory requirements for medical consumables and medical devices handled by the company.

• Process Domestic Bidders Certificate of Preference and other government certifications as required.

• Monitor FDA submissions and proactively follow up pending applications, deficiencies, renewals, and regulatory concerns.

• Provide management with a weekly regulatory status report identifying completed items, pending applications, upcoming expirations, issues, risks, and required actions.

• Monitor regulatory developments and advise management of changes that may affect the company’s products, licenses, importation, distribution, or business operations.

• Perform other regulatory and compliance-related duties that may be assigned by the immediate superior.

Qualifications

• Must be a licensed Pharmacist in the Philippines.
• At least one (1) year of relevant experience in Regulatory Affairs, preferably involving medical devices, healthcare products, pharmaceuticals, or related regulated products.
• Working knowledge of current Philippine FDA procedures, regulations, licensing, product registration, and compliance requirements.
• Experience handling FDA applications, renewals, licenses, permits, and regulatory documentation is preferred.
• Strong documentation, monitoring, follow-up, and records-management skills.
• Able to coordinate effectively with government agencies, consultants, manufacturers, suppliers, and overseas offices.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office, particularly Word, Excel, and PowerPoint.
• Highly organized, detail-oriented, and capable of managing multiple applications and regulatory deadlines simultaneously.
• Able to work independently, establish priorities, and elevate regulatory risks or delays when necessary.
• Willing to work on-site in Makati City.
• Full-time position.