Senior Regulatory Affairs Lead – Medical Device Submissions

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.

You will guide cross-functional teams, interpret FDA regulations, and ensure compliant documentation throughout product development and post-market activities. The ideal candidate has extensive experience with medical device submissions (510(k), IDE), strong technical writing skills, and a track record of delivering high-quality regulatory deliverables in a

Qualifications

• Deep knowledge of FDA medical device regulations and guidance.
• Experience preparing regulatory submissions (510(k), IDE, submissions).
• Strong technical writing and cross-functional collaboration skills.

Responsibilities

• Lead planning, authoring, compilation and submission of regulatory documents (510(k)s, IDEs, Pre-Submissions).
• Drive regulatory deliverables to completion and manage risks and timelines.
• Interpret FDA regulations and communicate requirements across the organization.

Skills

FDA regulations

Regulatory submissions

Technical writing

Project management

Cross-functional collab

ISO 13485

Education

Bachelor's degree in Engineering/Life Sciences

RAC certification preferred

Job description

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

You will guide cross-functional teams, interpret FDA regulations, and ensure compliant documentation throughout product development and post-market activities. The ideal candidate has extensive experience with medical device submissions (510(k), IDE), strong technical writing skills, and a track record of delivering high-quality regulatory deliverables in a