Summary

In the Urology division, we continually advance the quality of patient care with innovative Urology solutions. We are looking to hire an enthusiastic individual for a Senior Regulatory Affairs Specialist position (hybrid work mode) supporting our rapidly growing active implantable device portfolio. This role will be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process, as well as developing regulatory strategies. The role requires strong US, EU, and international regulatory experience that can be leveraged to help support international expansion. In this role, you'll be part of a high-functioning, close-knit Regulatory Affairs team responsible for support of submissions and on-going regulatory compliance through partnership with our global R&D, manufacturing, clinical, and quality teams.

Job description

About this role

In the Urology division, we continually advance the quality of patient care with innovative Urology solutions. We are looking to hire an enthusiastic individual for a Senior Regulatory Affairs Specialist position (hybrid work mode) supporting our rapidly growing active implantable device portfolio. This role will be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process, as well as developing regulatory strategies. The role requires strong US, EU, and international regulatory experience that can be leveraged to help support international expansion. In this role, you'll be part of a high-functioning, close-knit Regulatory Affairs team responsible for support of submissions and on-going regulatory compliance through partnership with our global R&D, manufacturing, clinical, and quality teams.

Your responsibilities will include

Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed
Supports the coordination, drafting, and submitting of U.S. and EU regulatory filings for new and modified Class III products
Provides technical reviews of test protocols and reports
Assesses labeling materials, including Instructions for Use
Represents RA on cross functional project teams
Works as liaison with International BSC Regulatory colleagues on various projects, including providing support with international regulatory filings
Supports highly technical or major business segment product lines, special projects or strategic initiatives

Required Qualifications

A minimum of a Bachelor's Degree in a scientific, technical, or related discipline
A minimum of 4 years Regulatory Affairs experience in the medical industry
Prior experience with 510(k) submissions, EU MDR or international regulatory registrations

Preferred Qualifications

Prior experience with PMA submissions or Class III submissions
Prior experience with active implantable devices, active devices, or long-term implants
Working knowledge of FDA, EU and international regulations for medical devices
General understanding of product development process, design control and quality system regulations
Ability to simultaneously manage several projects
Proficiency with Microsoft Office
Effective research and analytical skills
Effective written and oral communication, technical writing and editing skills
Ability to work independently with minimal supervision

Requirements

A minimum of a Bachelor's Degree in a scientific, technical, or related discipline
A minimum of 4 years Regulatory Affairs experience in the medical industry
Prior experience with 510(k) submissions, EU MDR or international regulatory registrations
Prior experience with PMA submissions or Class III submissions
Prior experience with active implantable devices, active devices, or long-term implants
Working knowledge of FDA, EU and international regulations for medical devices
General understanding of product development process, design control and quality system regulations
Ability to simultaneously manage several projects
Proficiency with Microsoft Office
Effective research and analytical skills
Effective written and oral communication, technical writing and editing skills
Ability to work independently with minimal supervision

Benefits

Health Insurance
Annual Bonus
Long-term Incentives

Company overview

Boston Scientific Corporation is a global leader in the development, manufacturing, and marketing of minimally invasive medical devices used in interventional medical specialties. Founded in 1979 and headquartered in Marlborough, Massachusetts, the company focuses on transforming patient lives through innovative medical solutions across a wide range of therapeutic areas including cardiology, endoscopy, urology, pulmonology, and neuromodulation. With approximately 53,000 employees worldwide and operations in 40 countries, Boston Scientific serves over 44 million patients annually. The company invests heavily in research and development, allocating $1.6 billion to R&D in 2024, and maintains a strong commitment to quality, patient safety, and meaningful innovation. Boston Scientific's product portfolio includes advanced technologies such as cardiac rhythm management devices, coronary stents, ablation systems, endoscopy equipment, and neuromodulation therapies, all designed to improve patient outcomes and quality of life through less invasive treatment options.