Regulatory Manager
SoluStaff
full-time
Posted on:
Location Type: Remote
Location: United States
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About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
FDA 510(k) submissionsregulatory strategiesSaMDFDA regulationsquality standards21 CFR Part 820ISO 13485IEC 62304
Soft Skills
cross-functional collaborationcommunication skills