QUALIFIED PERSON (QP) – MEDICAL DEVICES & IVD

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

QUALIFIED PERSON (QP) – MEDICAL DEVICES & IVD

Avio Healthcare Corporation is seeking a Qualified Person (QP) to support Philippine FDA licensing and regulatory operations for medical devices and In Vitro Diagnostic (IVD) products. The product portfolio includes medical devices and diagnostic products such as surgical disposables, laboratory instruments and reagents, hematology and biochemistry products, rapid diagnostic tests, agglutination tests, FIA products, and blood collection/vacuum tubes.

Key responsibilities

Serve as Avio Healthcare's designated Qualified Person (QP) for medical devices and IVD products

Support the application, maintenance, and renewal of the company's FDA License to Operate (LTO)

Prepare, review, and submit accurate regulatory documents, including CMDN, CMDR, and other market authorization requirements

Coordinate with the Philippine FDA regarding applications, deficiencies, clarifications, and inspections

Maintain product dossiers, regulatory records, and compliance documentation

Develop and maintain SOPs for storage, distribution, complaints, recalls, adverse events, and post-market surveillance

Coordinate with overseas manufacturers and suppliers to obtain required technical documents

Monitor regulatory updates and advise management on compliance requirements

About you

Registered pharmacist, medical technologist, nurse, physician, dentist, chemist, relevant engineering professional, or other qualified allied health or science professional

Valid PRC license required where applicable

Experience with FDA–CDRRHR, medical device or IVD registration, regulatory dossiers, and Distributor/Importer LTO applications strongly preferred

Organized, hands‑on, and capable of taking ownership of FDA regulatory compliance

Must disclose if currently serving as a QP or affiliated with another FDA-regulated establishment

About us

Avio Healthcare Corporation is a healthcare company that will be operating in the Philippines with a focus on FDA licensing and regulatory operations for medical devices and In Vitro Diagnostic products.