Regulatory Affairs Specialist - Medical Devices (PH)

Boston Scientific Corporation; Metro Manila; On-site; PHP 600,000 - 1,200,000; Full time

Job summary

Boston Scientific Pasig, Philippines is seeking a Regulatory Affairs Specialist (contractor) to manage regulatory activities for medical devices, ensuring timely approvals, compliance, and market access.

You will oversee registrations with the Philippine FDA – Center for Device Regulation, Radiation Health, and Research (CDRRHR), maintain technical documentation, and support cross-functional teams on regulatory matters.

Qualifications

• Strong regulatory writing and documentation skills.
• Solid understanding of medical device technical files and regulatory requirements.
• Excellent communication and stakeholder management skills.
• Ability to manage multiple priorities under tight timelines.
• Strong analytical thinking and problem-solving capabilities.
• High attention to detail and organizational skills.

Responsibilities

• Develop regulatory strategy and ensure compliance with Philippine FDA regulations (CDRRHR).
• Prepare, review, submit, and follow up on regulatory submissions (CMDN, CMDR, variations, renewals).
• Maintain regulatory databases and product documentation throughout the lifecycle.
• Liaise with FDA Philippines and respond to queries and deficiency letters.
• Collaborate with cross-functional teams to support product launches and lifecycle activities.

Skills

Regulatory writing

Documentation

Stakeholder mgmt

Prioritization

Analytical thinking

Attention to detail

Education

Bachelor’s degree

Job description

Boston Scientific Pasig, Philippines is seeking a Regulatory Affairs Specialist (contractor) to manage regulatory activities for medical devices, ensuring timely approvals, compliance, and market access.

You will oversee registrations with the Philippine FDA – Center for Device Regulation, Radiation Health, and Research (CDRRHR), maintain technical documentation, and support cross-functional teams on regulatory matters.