Regulatory Affairs Specialist, Medical Devices (PH)

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

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