Regulatory Affairs Specialist (contractor)

Boston Scientific Philippines, Inc.; Pasig; On-site; PHP 600,000 - 900,000; Full time

Job summary

Boston Scientific Philippines, Inc. is seeking a Regulatory Affairs Specialist for Medical Devices in the Philippines.

The role oversees regulatory activities to ensure timely approvals, compliance, and market access, including filings with the Philippine FDA (CDRRHR) and lifecycle management. The ideal candidate has a minimum of 2 years in regulatory affairs for medical devices, with strong knowledge of CMDN/CMDR and ISO 13485 exposure.

Qualifications

• Bachelor’s degree in a life‑science field; licensed pharmacist is an advantage.
• Minimum 2 years regulatory affairs experience in the medical device industry.
• Strong understanding of Philippine regulatory pathways (CMDN, CMDR).
• Experience interacting with FDA Philippines (CDRRHR) is required.

Responsibilities

• Support timely regulatory strategy and compliance for medical devices.
• Prepare, review, submit, and follow up on regulatory submissions (CMDN, CMDR, variations, renewals).
• Maintain regulatory databases, records, and lifecycle documentation; support audits.
• Liaise with FDA Philippines (CDRRHR) and manage regulatory communications.
• Collaborate with cross‑functional teams to support product launches and lifecycle activities.
• Coordinate post‑market surveillance with QA and regulatory teams.

Skills

Regulatory writing

Documentation

Stakeholder management

Regulatory strategy

Analytical thinking

Education

Bachelor’s degree in Pharmacy, Biology, Medical Technology, Engineering, or related life‑science field

Licensed Pharmacist or equivalent license is an advantage

Job description

Additional Locations: N/A

Diversity

• Innovation
• Caring
• Global Collaboration
• Winning Spirit
• High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Position Overview

The Regulatory Affairs Specialist for Medical Devices is responsible for managing regulatory activities required to ensure timely approval, compliance, and continued market access of medical device products in the Philippines. This includes overseeing product registrations with the Philippine FDA – Center for Device Regulation, Radiation Health, and Research (CDRRHR), maintaining regulatory compliance throughout the product lifecycle, and supporting cross‑functional teams on regulatory and technical matters.

Key Responsibilities

1. Regulatory Strategy & Compliance

• To support timely product approvals and market access for medical devices.
• Ensure full compliance with Philippine FDA (CDRRHR) regulations and relevant local administrative orders.
• Monitor regulatory changes and interpret their impact on current and future products; communicate updates to internal stakeholders.

2. Product Registration & Lifecycle Management

• Prepare, review, submit, and follow up on regulatory submissions (CMDN, CMDR, variations, and renewals).
• Compile and validate technical documentation
• Track and maintain regulatory approvals, licenses, and product documentation throughout the product lifecycle.
• Maintain accurate and up‑to‑date regulatory databases and records.
• Support internal and external audits related to regulatory compliance.

3. Government Liaison & External Engagement

• Serve as a liaison with FDA Philippines (CDRRHR) to facilitate regulatory interactions.
• Manage regulatory communications, including responses to queries, deficiency letters, and compliance issues.
• Represent the company in government audits, regulatory inspections, and industry association meetings.

4. Cross-functional Collaboration

• Collaborate with Commercial, Quality Assurance, Supply Chain, Marketing, and Regional Regulatory teams to support product launches and lifecycle activities.
• Provide regulatory guidance on claims, labeling, promotional materials, and device modifications.
• Support internal and external audits related to regulatory compliance.

5. Post-Market Surveillance & Compliance

• Coordinate with QA for post‑market surveillance (PMS) requirements and ensure timely reporting to FDA.

Qualifications

Education

• Bachelor’s degree in Pharmacy, Biology, Medical Technology, Engineering, or related life‑science field.
• Licensed Pharmacist or equivalent professional license is an advantage.

Experience

• 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, AMDD, and global medical device standards is highly preferred.

Skills & Competencies

• 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.

Key Attributes

• Strong Integrity and compliance mindset
• Proactive and highly organized
• Ability to influence and collaborate cross‑functionally
• Adaptable in a fast‑paced and regulated environment

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions.

Learn more atwww.bostonscientific.comand follow us onLinkedIn.