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Regulatory Affairs Specialist

Posted Jul 24, 2026

Additional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 OverviewThe 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.<div style="text-align: center; margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;" align="center"><hr align="center" size="2" width="100%"></div>Key Responsibilities1.

Regulatory Strategy & Compliance<ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"><li style="margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">To support timely product approvals and market access for medical devices.</li><li style="margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Ensure full compliance with Philippine FDA (CDRRHR) regulations and relevant local administrative orders.</li><li style="margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Monitor regulatory changes and interpret their impact on current and future products; communicate updates to internal stakeholders.</li></ul>2. Product Registration & Lifecycle Management<ul style="margin-bottom: 0in; margin-top: 0px;"><li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Prepare, review, submit, and follow up on regulatory submissions (CMDN, CMDR, variations, and renewals). </li><li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Compile and validate technical documentation </li><li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Track and maintain regulatory approvals, licenses, and product documentation throughout the product lifecycle.</li><li style="margin: 0in 0in 0in 0px; line-height: 15pt; font-size: 12pt; font-family: Aptos, sans-serif;">Maintain accurate and up-to-date regulatory databases and records. </li><li style="margin: 0in 0in 0in 0px; line-height: 15pt; font-size: 12pt; font-family: Aptos, sans-serif;">Support internal and external audits related to regulatory compliance.</li></ul>3.

Government Liaison & External Engagement<ul style="margin-bottom: 0in; margin-top: 0px;"><li style="margin: 0in 0in 0in 0px; line-height: 15pt; font-size: 12pt; font-family: Aptos, sans-serif;">Serve as a liaison with FDA Philippines (CDRRHR) to facilitate regulatory interactions.</li><li style="margin: 0in 0in 0in 0px; line-height: 15pt; font-size: 12pt; font-family: Aptos, sans-serif;">Manage regulatory communications, including responses to queries, deficiency letters, and compliance issues.</li></ul><ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"><li style="margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Represent the company in government audits, regulatory inspections, and industry association meetings.</li></ul>4. Cross-functional Collaboration<ul style="margin-bottom: 0in; margin-top: 0px;"><li style="margin: 0in 0in 0in 0px; line-height: 15pt; font-size: 12pt; font-family: Aptos, sans-serif;">Collaborate with Commercial, Quality Assurance, Supply Chain, Marketing, and Regional Regulatory teams to support product launches and lifecycle activities.</li></ul><ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"><li style="margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Provide regulatory guidance on claims, labeling, promotional materials, and device modifications.</li></ul><ul style="margin-bottom: 0in; margin-top: 0px;"><li style="margin: 0in 0in 0in 0px; line-height: 15pt; font-size: 12pt; font-family: Aptos, sans-serif;">Support internal and external audits related to regulatory compliance.</li></ul> 5.

Post-Market Surveillance & Compliance<ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"><li style="margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Coordinate with QA for post-market surveillance (PMS) requirements and ensure timely reporting to FDA.</li></ul><div style="text-align: center; margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;" align="center"><hr align="center" size="2" width="100%"></div>QualificationsEducation<ul style="margin-bottom: 0in; margin-top: 0px;"><li style="margin: 0in 0in 0in 0px; font-size: 12pt; font-family: Aptos, sans-serif;">Bachelor’s degree in Pharmacy, Biology, Medical Technology, Engineering, or related life-science field.</li><li style="margin: 0in 0in 0in 0px; font-size: 12pt; font-family: Aptos, sans-serif;">Licensed Pharmacist or equivalent professional license is an advantage.</li></ul>Experience<ul style="margin-bottom: 0in; margin-top: 0px;"><li style="margin: 0in 0in 0in 0px; font-size: 12pt; font-family: Aptos, sans-serif;">Minimum 2 years of regulatory affairs experience in the medical device industry.</li><li style="margin: 0in 0in 0in 0px; font-size: 12pt; font-family: Aptos, sans-serif;">Strong understanding of Philippine regulatory pathways (CMDN, CMDR).</li><li style="margin: 0in 0in 0in 0px; font-size: 12pt; font-family: Aptos, sans-serif;">Experience interacting with FDA Philippines (CDRRHR) is required.</li><li style="margin: 0in 0in 0in 0px; font-size: 12pt; font-family: Aptos, sans-serif;">Exposure to ISO 13485, AMDD, and global medical device standards is highly preferred.</li></ul>Skills & Competencies<ul style="margin-bottom: 0in; margin-top: 0px;"><li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Strong regulatory writing and documentation skills. </li><li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Solid understanding of medical device technical files and regulatory requirements. </li><li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Excellent communication and stakeholder management skills. </li><li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Ability to manage multiple priorities under tight timelines. </li><li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Strong analytical thinking and problem-solving capabilities. </li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">High attention to detail and organizational skills.</li></ul><div style="text-align: center; margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;" align="center"><hr align="center" size="2" width="100%"></div>Key Attributes<ul style="margin-bottom: 0in; margin-top: 0px;"><li style="margin: 0in 0in 0in 0px; font-size: 12pt; font-family: Aptos, sans-serif;">Strong Integrity and compliance mindset</li><li style="margin: 0in 0in 0in 0px; font-size: 12pt; font-family: Aptos, sans-serif;">Proactive and highly organized</li><li style="margin: 0in 0in 0in 0px; font-size: 12pt; font-family: Aptos, sans-serif;">Ability to influence and collaborate cross-functionally</li><li style="margin: 0in 0in 0in 0px; font-size: 12pt; font-family: Aptos, sans-serif;">Adaptable in a fast-paced and regulated environment</li></ul> 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 <a href="https://c212.net/c/link/?t=0&l=en&o=4007299-1&h=2437349916&u=https%3A%2F%2Fwww.bostonscientific.com%2F&a=www.bostonscientific.com" target="_blank" rel="noreferrer noopener">www.bostonscientific.com</a> and follow us on <a href="https://www.linkedin.com/company/boston-scientific/" target="_blank" rel="noreferrer noopener">LinkedIn</a>.

Originally posted by Boston Scientific Corporation. View original posting

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