Regulatory Affairs Specialist I

$56,500 - $107,300/Yr

Boston Scientific - Maple Grove, MN

Full-time - Entry Level

Hybrid - Maple Grove, MN

Merchant Wholesalers, Durable Goods

About the position

Boston Scientific (BSC) is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We are looking for a Regulatory Affairs Specialist I to work in our rapidly growing Coronary Therapies franchise. We are looking for future regulatory leaders to partner with our global R&D and quality teams in our continued journey to evolve technologies and drive future generations of products. We seek a dynamic individual focused on professional development in an innovative environment offering a diverse mix of regulatory opportunities encompassing the full life cycle of cardiovascular devices. If you are interested in a varied and important role and think you will be a good fit, please apply. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office at least three days per week.

Responsibilities

• Assists in developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Assists in drafting regulatory strategies for new and modified medical devices
• Assists core team members on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle
• Assists with preparation and submission of regulatory applications, as well as internal regulatory file documentation
• Assists with reviewing device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes
• Assists with reviews and signs-off on product and manufacturing changes for compliance with applicable regulations

Requirements

• Bachelor's Degree in life sciences, engineering or an equivalent
• 1+ year of technical or medical device experience (in industry or academics)
• Basic computer skills, including experience with Microsoft Office, Word, Excel, PowerPoint and Adobe Acrobat

Nice-to-haves

• Ability to communicate complex ideas clearly and simply both orally and in writing
• Demonstrated ability to effectively manage multiple projects and priorities in a timeline driven environment
• Team player with excellent interpersonal skills

Benefits

• 401k
• health_insurance
• dental_insurance
• vision_insurance
• life_insurance
• disability_insurance
• paid_holidays
• tuition_reimbursement
• professional_development