Senior Manager, Regulatory Affairs

📋 Description

• Develop and execute global regulatory strategies for digital products, aligned with business
• Determine device classification, qualification, and pathway for software functions, including
• Advise cross-functional leaders on regulatory risk, timelines, and trade-offs early in the design
• Represent Regulatory Affairs on digital product core teams and governance forums.
• Manage the regulatory assessment and ongoing oversight of the non-medical device portfolio of
• Lead preparation, review, and submission of 510(k), De Novo, and other premarket submissions.

🎯 Requirements

• Bachelor's degree in engineering, life sciences, computer science, or a related technical field.
• 8+ years of regulatory affairs experience in medical devices, including 3+ years of direct
• Demonstrated success leading US premarket submissions for software-containing devices.
• Working knowledge of FDA regulations (21 CFR 820 / QMSR, 21 CFR Part 11), EU MDR, and software
• 3+ years of experience leading or managing people or cross-functional project teams.
• Strong written and verbal communication skills, with proven ability to influence senior

🎁 Benefits

• Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.