Job Summary

• The Regulatory Affairs Fellow supports the review and approval of advertising, promotional, sales support, and training materials for Electrophysiology medical devices.
• This role applies a risk-based regulatory mindset to ensure materials are accurate, balanced, appropriately substantiated, and aligned with applicable regulations and internal procedures.
• The Fellow partners cross-functionally to enable compliant, effective communication that supports business objectives while protecting patients and the company.

Matching Summary

Salary

Base: $125800 - $239000; Bonus/Equity: Annual bonus target and long-term incentives may be offered; Benefits: See www.bscbenefitsconnect.com

Skills & Requirements

Key Requirements

• Bachelor's degree in life sciences or related
• 10 years' experience in Regulatory Affairs
• Experience reviewing medical device promotional materials
• Working knowledge of FDA and EU regulatory frameworks
• Experience evaluating product claims
• Experience assessing clinical data for claims
• Experience with fair balance and risk communication

Work Rights