Senior Regulatory Affairs Specialist

Boston Scientific•Irvine, CA

13h•Hybrid

About The Position

At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work. We offer a collaborative culture that values diversity and prioritizes initiatives that promote awareness and inclusion, celebrating personal, cultural, and demographic differences of our customers, patients, and workforce. 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.

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

Nice To Haves

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

Responsibilities

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