Regulatory Affairs Specialist | Medical Devices (Philippines)

Boston Scientific; Philippines; On-site; PHP 400,000 - 800,000; Full time

Job summary

Boston Scientific in the Philippines is seeking a Regulatory Affairs Specialist to manage regulatory activities, ensure timely approvals, and maintain market access for medical devices. You will oversee registrations with the Philippine FDA and support cross-functional teams on regulatory and technical matters.

The role requires at least 2 years of regulatory experience in the medical device sector, familiarity with CMDN/CMDR, and collaboration with FDA Philippines.

Qualifications

• Minimum 2 years of regulatory affairs experience in the medical device industry.
• Strong understanding of Philippine regulatory pathways (CMDN, CMDR).
• Experience interacting with FDA Philippines (CDRRHR) is required.
• Exposure to ISO 13485 and global medical device standards is highly preferred.

Responsibilities

• Support product registrations and lifecycle management for medical devices.
• Coordinate with FDA Philippines (CDRRHR) and respond to queries and deficiencies.
• Collaborate with Commercial, QA, Supply Chain, Marketing, and Regional Regulatory teams.
• Provide regulatory guidance on labeling, claims, and device modifications.
• Coordinate audits related to regulatory compliance and post-market surveillance.

Skills

Regulatory writing

Regulatory submissions

Cross-functional collaboration

Communication

Education

Bachelor’s degree in Pharmacy or life sciences

Tools

Regulatory databases

Job description

Boston Scientific in the Philippines is seeking a Regulatory Affairs Specialist to manage regulatory activities, ensure timely approvals, and maintain market access for medical devices. You will oversee registrations with the Philippine FDA and support cross-functional teams on regulatory and technical matters.

The role requires at least 2 years of regulatory experience in the medical device sector, familiarity with CMDN/CMDR, and collaboration with FDA Philippines.