Regulatory Affairs Specialist II, LAAC - IC

Recruiter: Spencer Gregory HaleRegulatory Affairs Specialist II, LAAC – ICAbout the role:At Boston Scientific, you’ll discover a career with 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.We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist II position (hybrid work mode) supporting our rapidly growing Left Atrial Appendage Closure (LAAC) device portfolio:https://www.bostonscientific.com/en-US/products/laac-system.htmlIn 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 and quality teams.Key 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 II and Class III products• Supports clinical activities as needed, including post-approval study and IDE annual reporting• Provides technical reviews of test protocols and reports• Assesses labeling materials, including Instructions for Use• Represents RA on cross functional project teams• Participates in corporate and departmental training• Works as liaison with International BSC Regulatory colleagues on various projects, including providing support with international regulatory filingsMinimum Qualifications:• BA/BS Degree• 2 years of regulatory affairs (medical device) experience• Ability to communicate complex ideas clearly and concisely (both verbally and in writing)• Demonstrated ability to effectively manage multiple projects and priorities in a timeline driven environment• Team player with excellent interpersonal skills• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe AcrobatDesired Qualifications:• Current or previous BSC Regulatory experience• Previous experience with Class II and III medical devices change assessments and submissions• Experience working directly with FDA, notified bodies and/or international health authorities• BA/BS Degree in life sciences, engineering or an equivalentRequisition ID: 587402Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.