Senior Regulatory Affairs Lead – Medical Devices

Diality, Inc.; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Diality, Inc. is seeking a Principal Regulatory Affairs Specialist to lead regulatory submissions for the Moda-flx Hemodialysis System and provide cross-functional regulatory guidance.

You will manage 510(k)s, IDEs, and international submissions while ensuring compliance across development and post-market activities. The ideal candidate has extensive experience translating complex technical data into regulatory documentation, excels in fast-paced startup settings, and can drive projects to

Qualifications

• 7–11+ years of medical device regulatory affairs experience
• Experience preparing FDA submissions (510(k), IDE, Pre-Submissions)
• Startup/early-stage regulatory environments
• Dialysis or renal medical device experience preferred

Responsibilities

• Lead planning, authoring, and submission of regulatory filings (510(k), IDEs, Pre-Submissions)
• Drive regulatory deliverables to completion and mitigate risks
• Ensure submissions are compliant and well-documented
• Prepare briefing materials and agency communications
• Coordinate regulatory activities across Engineering, Quality, Clinical, Operations, and PM
• Interpret FDA regulations and communicate requirements to teams
• Support design controls, risk management, and product claims from a regulatory view
• Assess regulatory impact of changes and advise on pathways
• Conduct regulatory intelligence on trends and watchdog actions
• Support MDRs and post-market surveillance collaboration

Skills

FDA regulations

EU regulatory frameworks

Technical writing

Product development

Data analysis

Project management

Stakeholder collaboration

MS Office

Education

Bachelor's degree in Engineering/Life Sciences

RAC Certification (preferred)

Tools

Microsoft Office

Adobe Acrobat

Job description

Diality, Inc. is seeking a Principal Regulatory Affairs Specialist to lead regulatory submissions for the Moda-flx Hemodialysis System and provide cross-functional regulatory guidance.

You will manage 510(k)s, IDEs, and international submissions while ensuring compliance across development and post-market activities. The ideal candidate has extensive experience translating complex technical data into regulatory documentation, excels in fast-paced startup settings, and can drive projects to