People Powering Technology
Regulatory Manager
Location
United States
Posted
99 days ago
Salary
0
Seniority
Senior
Job Description
Regulatory Manager
SoluStaff
• Lead preparation and submission of FDA 510(k) filings for healthcare software and digital health products • Develop and execute regulatory strategies supporting product development and commercialization • Collaborate with product development, quality, clinical, and engineering teams to ensure regulatory compliance • Interpret FDA guidance related to medical device software and digital health technologies • Partner with global regulatory teams to support international regulatory initiatives
Job 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
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