Regulatory Affairs Specialist (Contractor) – Medical Devices

Boston Scientific Gruppe; Pasig; On-site; PHP 600,000 - 900,000; Full time

Job summary

Boston Scientific Philippines is seeking a Regulatory Affairs Specialist (contractor) to manage regulatory activities for medical devices in the Philippines, including submissions to the FDA Philippines (CDRRHR) and lifecycle management. The role requires coordinating with cross-functional teams to ensure ongoing market access and regulatory compliance.

The ideal candidate has 2+ years in regulatory affairs for medical devices, familiarity with CMDN/CMDR, and experience interacting with FDA

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).

Responsibilities

• Support timely product registrations and lifecycle management for medical devices.
• Coordinate with FDA Philippines (CDRRHR) and internal teams on regulatory submissions.
• Provide regulatory guidance on labeling, claims, and promotional materials.
• Collaborate with QA, Supply Chain, Marketing, and regional Regulatory teams on launches and lifecycle activities.
• Maintain regulatory databases and assist audits.

Skills

Regulatory affairs

Regulatory writing

Documentation

Stakeholder management

Cross-functional collaboration

Communication

Education

Bachelor’s degree in Pharmacy / Biology / Medical Technology / Engineering

Licensed Pharmacist (advantage)

Job description

Boston Scientific Philippines is seeking a Regulatory Affairs Specialist (contractor) to manage regulatory activities for medical devices in the Philippines, including submissions to the FDA Philippines (CDRRHR) and lifecycle management. The role requires coordinating with cross-functional teams to ensure ongoing market access and regulatory compliance.

The ideal candidate has 2+ years in regulatory affairs for medical devices, familiarity with CMDN/CMDR, and experience interacting with FDA