FDA REGULATORY OFFICER

UNITED MEDICAL SUPPLY; Pasig; On-site; PHP 268,000 - 469,000; Full time

Job summary

UNITED MEDICAL SUPPLY is seeking a regulatory assistant to file applications with health authorities. You will prepare and submit documents for product registration, renewals, and amendments, including CMDR and CMDN, ensuring compliance with applicable laws.

You will act as the main liaison between the company and the FDA, track updates to applications and changes in health regulations, and help the team prepare for government inspections.

Qualifications

• Prepare and submit documents for product registration, renewals, and amendments including CMDR and CMDN.
• Act as main contact between the company and the Food and Drug Administration.
• Monitor updates of FDA applications and changes to health laws.
• Support audits and inspections by government agencies.

Responsibilities

• Prepare and submit documents for product registration, renewals and amendments including CMDR and CMDN.
• Serve as main liaison with FDA and other regulatory bodies.
• Track regulatory updates and changes in health laws.
• Assist the team in readiness for government agency inspections.

Job description

FILING APPLICATIONS: Prepare and submit documents for product registration, renewals and amendments ((including Certificate of Medical Device Registration( CMDR) and Certificate of Medical Device Notification (CMDN).

CONTACT TO AGENCIES: Act as the main contact between company and the Food and Drug Administration .

TRACK UPDATES: Monitoring updates of applications and changes incurred by FDA and its health laws.

SUPPORT AUDITS: Help the team get ready for government agency inspections