REGULATORY AFFAIRS STAFF FOR MEDICAL DEVICE

Surgtech medical supplies; Cebu City; On-site; PHP 400,000 - 660,000; Full time

Job summary

Surgtech Medical Supplies, Inc. is seeking a Regulatory Affairs Specialist to manage regulatory requirements for medical device products in the Philippines. The role involves handling FDA applications, licenses, and renewals, and coordinating with agencies.

Candidates should have at least 1 year of regulatory affairs experience in medical devices, familiarity with LTO and registration/notification, and be able to work independently based in Cebu with strong communication skills.

Qualifications

• At least 1 year of Regulatory Affairs experience in the medical device industry.
• Experience handling Philippine FDA medical device applications and requirements.
• Familiar with LTO and medical device registration/notification processes.
• Organized, detail-oriented, and able to monitor multiple applications and deadlines.

Responsibilities

• Process and monitor FDA applications, licenses, permits, and renewals
• Assist with License to Operate (LTO) and medical device product registration/notification requirements
• Prepare, review, and organize regulatory documents for submission
• Monitor expiration dates and ensure timely renewal of licenses and registrations
• Coordinate and follow up with the Philippine FDA and other government agencies
• Coordinate with suppliers for regulatory and product documentation
• Maintain complete and updated regulatory records
• Ensure compliance with applicable medical device regulatory requirements
• Provide regular updates on pending applications and regulatory deadlines

Skills

Regulatory Affairs

Medical devices

Communication

Independent work

Job description

About the role

Surgtech Medical Supplies, Inc. is looking for an experienced Regulatory Affairs Specialist to handle and assist with regulatory requirements for our medical device products.

Key responsibilities

• Process and monitor FDA applications, licenses, permits, and renewals

• Assist with License to Operate (LTO) and medical device product registration/notification requirements

• Prepare, review, and organize regulatory documents for submission

• Monitor expiration dates and ensure timely renewal of licenses and registrations

• Coordinate and follow up with the Philippine FDA and other government agencies

• Coordinate with suppliers for regulatory and product documentation

• Maintain complete and updated regulatory records

• Ensure compliance with applicable medical device regulatory requirements

• Provide regular updates on pending applications and regulatory deadlines

About you

• At least 1 year of Regulatory Affairs experience in the medical device industry

• Experience handling Philippine FDA medical device applications and requirements

• Familiar with LTO and medical device registration/notification processes

• Organized, detail-oriented, and able to monitor multiple applications and deadlines

• Good written and verbal communication skills

• Able to work independently with minimal supervision

• Willing to be based in Cebu