Regulatory QP – Medical Devices & IVD Licensing Lead

HEMERA INTERNATIONAL PTE LTD; Manila; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

Avio Healthcare Corporation is seeking a Qualified Person (QP) to support Philippine FDA licensing and regulatory operations for medical devices and IVD products, including maintaining the License to Operate and compiling regulatory dossiers.

The role requires a licensed healthcare professional with regulatory experience, organized, proactive, and able to coordinate with the Philippine FDA and overseas manufacturers.

Qualifications

• Registered professionals with regulatory experience in medical devices and IVD.
• Experience with FDA–CDRRHR processes and LTO applications preferred.
• Ability to prepare, submit, and maintain regulatory dossiers.

Responsibilities

• Serve as the designated Qualified Person for medical devices and IVD products.
• Support FDA License to Operate applications, maintenance, and renewal.
• Prepare, review, and submit CMDN, CMDR, and market authorization documents.
• Coordinate with FDA on applications, deficiencies, and inspections.
• Maintain regulatory records and product dossiers.
• Develop SOPs for storage, distribution, recalls, and post‑market surveillance.
• Coordinate with overseas manufacturers for technical documents.
• Monitor regulatory updates and advise management on compliance.

Skills

Regulatory affairs

FDA licensing

Documentation

Ownership

Education

PRC license or equivalent

Job description

Avio Healthcare Corporation is seeking a Qualified Person (QP) to support Philippine FDA licensing and regulatory operations for medical devices and IVD products, including maintaining the License to Operate and compiling regulatory dossiers.

The role requires a licensed healthcare professional with regulatory experience, organized, proactive, and able to coordinate with the Philippine FDA and overseas manufacturers.