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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

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.
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.
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.
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.
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

Requisition ID: 631359

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 by providing a 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, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.