Regulatory Affairs Manager-US

Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. The role will focus on FDA 510(k) submissions and regulatory pathways for Software as a Medical Device (SaMD) within a global, multinational environment.

Requirements

• 5–10+ years of regulatory affairs experience in medical devices or healthcare software
• Proven experience with FDA 510(k) submissions, ideally for software-based medical devices
• Strong knowledge of SaMD, FDA regulations, and quality standards (21 CFR Part 820, ISO 13485, IEC 62304)
• Experience working within a multinational organization
• Strong cross-functional collaboration and communication skills

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship