Regulatory Affairs Specialist, Medical Devices Philippines

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

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.