SoluStaff

People Powering Technology

Regulatory Manager

ComplianceComplianceFull TimeRemoteTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

4 days ago

Salary

Not specified

5 yrs expEnglish

Job Description

• 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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