REGULATORY AFFAIRS STAFF FOR MEDICAL DEVICE

Surgtech medical supplies; Pasig; On-site; PHP 420,000 - 640,000; Full time

Job summary

Endocare Philippines is a growing medical device company seeking an experienced Regulatory Affairs Officer to strengthen our regulatory team. You will manage FDA applications, licenses, and registrations, coordinating with the Philippine FDA and other agencies to ensure timely approvals for multiple products.

The ideal candidate has hands-on regulatory experience, is highly organized, and can handle several submissions simultaneously while meeting deadlines.

Qualifications

• At least 2 years hands-on regulatory affairs experience.
• Experience with Philippine FDA applications.
• Experience with LTO, CMDN/CMDR.
• Familiar with FDA documentation and deficiency handling.
• Able to manage multiple regulatory applications.
• Highly organized and detail-oriented.
• Strong written and verbal communication skills.
• Able to work with minimal supervision and meet deadlines.
• Preferred science-related degree.

Responsibilities

• Process and monitor FDA applications for medical devices.
• Handle LTO applications, renewals, variations.
• Prepare CMDN/CMDR registrations.
• Prepare, review, and submit regulatory documents.
• Coordinate with Philippine FDA and agencies.
• Monitor pending applications and follow up status.
• Respond to deficiencies and queries.
• Coordinate with suppliers for documents for product registration.
• Maintain a regulatory tracker with statuses, submission dates, and expirations.
• Monitor renewal deadlines for licenses and registrations.

Skills

Regulatory Affairs

Attention to detail

Project management

Communication skills

Education

Pharmacy, Medical Technology, Biology, Biomedical/Medical Sciences, Chemistry, Engineering

Tools

Microsoft Office

Google Workspace

Job description

About the role

Endocare Philippines is a growing medical device company seeking an experienced Regulatory Affairs Officer to strengthen our regulatory team. As a new and expanding company, we are currently processing multiple FDA licenses, product registrations, permits, and other regulatory requirements. We are specifically looking for someone with actual hands‑on experience in Philippine FDA regulatory processing for medical devices who can immediately contribute to completing our regulatory requirements.

Key responsibilities

• Process and monitor FDA applications for medical devices
• Handle License to Operate (LTO) applications, renewals, and variations
• Prepare and process CMDN / CMDR and other applicable medical-device registrations
• Prepare, review, organize, and submit regulatory documents and technical requirements
• Coordinate directly with the Philippine FDA and other relevant government agencies
• Monitor pending applications and actively follow up their status
• Respond to FDA deficiencies, queries, and additional documentary requirements
• Coordinate with foreign and local suppliers/principals to obtain documents required for product registration
• Maintain a complete regulatory tracker showing all products, applications, submission dates, status, deficiencies, approvals, and expiration dates
• Monitor renewal deadlines for licenses, registrations, and permits

About you

• At least 2 years of hands‑on Regulatory Affairs experience, preferably in a medical device company
• Actual experience processing applications with the Philippine FDA
• Experience with medical‑device LTO, CMDN and/or CMDR applications
• Familiar with FDA documentation, submissions, follow‑ups, and deficiency handling
• Able to manage multiple regulatory applications simultaneously
• Highly organized and detail‑oriented
• Strong written and verbal communication skills
• Proficient in Microsoft Office and/or Google Workspace
• Able to work with minimal supervision and meet deadlines
• Preferred educational background: Pharmacy, Medical Technology, Biology, Biomedical/Medical Sciences, Chemistry, Engineering or other relevant science‑related courses

About us

Endocare Philippines is a growing medical device company expanding its operations with numerous regulatory applications and permits that need to be completed.