Boston Scientific Regulatory Affairs Specialist II LAAC - IC 

United States, Minnesota, Maple Grove 

150268406

Spencer Gregory Hale

About the role:

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:

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 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 filings

Minimum 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 Acrobat

Desired 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 equivalent

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to aprohibited substancetest as a requirement. The goal of theprohibited substancetesting is to increase workplace safety in compliance with the applicable law.