Senior Regulatory Affairs Lead, Medical Devices

Diality; Irvine (CA); Presencial; USD 150.000 - 210.000; Jornada completa

Descripción de la vacante

Diality seeks a Principal Regulatory Affairs Specialist to lead regulatory submissions for the Moda-flx Hemodialysis System, including 510(k)s, IDEs, and international filings. You will guide cross-functional teams with regulatory strategy, ensure compliant documentation, and manage agency interactions to enable timely approvals.

The ideal candidate has extensive experience in medical device regulatory affairs, strong technical writing skills, and the ability to thrive in a fast-paced startup

Formación

• Deep knowledge of FDA medical device regulations (21 CFR 820, ISO 13485, ISO 14971).
• Strong knowledge of EU and OUS regulatory frameworks.
• Expert-level technical writing and submission authoring skills.
• Strong understanding of medical device product development processes.

Responsabilidades

• Lead planning, development, authoring, compilation, submission and maintenance of regulatory submissions (510(k)s, IDEs, IDE supplements, Pre-Submissions).
• Drive regulatory deliverables to completion and mitigate regulatory risks across timelines.
• Ensure submissions are scientifically sound, technically accurate, and compliant with regulations and guidance.
• Support agency interactions with briefing materials and meeting preparation.
• Coordinate regulatory submission activities across Engineering, Quality, Clinical, Operations, and PM teams.
• Serve as regulatory SME for product development teams; interpret FDA regulations and standards.
• Provide regulatory support through product lifecycle including design controls, risk mgmt, V&V and claims alignment.
• Assess regulatory impact of product changes and advise on pathways and submission needs.
• Conduct regulatory intelligence research and analyze post-market data for decision-making.
• Support MDR review and post-market surveillance; collaborate with Quality, Clinical, and Engineering.
• Review product claims and labeling from regulatory perspective.

Conocimientos

FDA regulations

EU regulatory

Technical writing

Regulatory strategy

Cross-functional collaboration

Project management

Microsoft Office

Adobe Acrobat

Educación

Bachelor’s degree in Engineering/Biology/Life Sciences

RAC certification

Herramientas

FDA submission tools

Microsoft Word

Adobe Acrobat

Descripción del empleo

Diality seeks a Principal Regulatory Affairs Specialist to lead regulatory submissions for the Moda-flx Hemodialysis System, including 510(k)s, IDEs, and international filings. You will guide cross-functional teams with regulatory strategy, ensure compliant documentation, and manage agency interactions to enable timely approvals.

The ideal candidate has extensive experience in medical device regulatory affairs, strong technical writing skills, and the ability to thrive in a fast-paced startup