Regulatory Affairs Specialist – Medical Devices

About the role

Boston Scientific is seeking a Regulatory Affairs Specialist to lead regulatory activities for medical device products in the Philippines. You will ensure timely product approvals, maintain compliance throughout the product lifecycle, and act as the primary liaison with the Philippine FDA (CDRRHR).

Key responsibilities

• Prepare, submit, and follow up on regulatory submissions (CMDN, CMDR, variations, renewals).
• Monitor Philippine FDA regulations, interpret changes, and communicate impacts to internal teams.
• Maintain accurate regulatory databases, licenses, and product documentation.
• Serve as the point of contact with FDA Philippines, handling queries, deficiency letters, and audit participation.
• Collaborate with Commercial, QA, Supply Chain, Marketing, and Regional Regulatory teams to support launches and post‑market activities.
• Coordinate post‑market surveillance reporting and support internal/external audits.

Required profile

• Bachelor’s degree in Pharmacy, Biology, Medical Technology, Engineering, or a related life‑science field.
• Minimum 2 years of regulatory affairs experience in the medical device industry.
• Strong understanding of Philippine FDA (CDRRHR) regulations and local administrative orders.

Required skills

• Regulatory submission preparation and review.
• Regulatory database management.
• Effective communication with government agencies.
• Cross‑functional collaboration.

What we offer

• Access to the latest tools, information, and training.
• Opportunities for career advancement within a global, high‑performing team.
• Supportive environment that encourages innovation and collaboration.