Senior Regulatory Specialist

Boston Scientific • Maple Grove, MN

1d • $82,600 - $156,900 • Hybrid

About The Position

About the role: Responsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance. Work Mode: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office at three days per week.

Requirements

• Minimum of 5 years of experience with a university degree or the equivalent combination of education and experience required; advanced/graduate degree preferred for some disciplines

Responsibilities

• Begins to act as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions under review.
• Assists with departmental policy and procedure implementation.
• Assists with Regulatory Affairs training to cross functional groups.
• Implements regulatory strategies for new and modified medical devices.
• Acts as a core member on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
• Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
• Reviews device labeling and advertising materials for compliance with global submissions and applicable regulations; analyzes and recommends appropriate changes.
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees