Director, Software Quality and Regulatory Compliance (Remote)

 Delfi Diagnostics - Company site
 October 13, 2021
 Flag job
 Palo Alto, CA
About Us
Our mission is to cure cancer through high performance, accessible early cancer detection.  That means saving lives. 
Delfi Diagnostics is a Johns Hopkins spinoff focused on the non-invasive detection of cancer at earlier stages, when it is most curable. DELFI uses artificial intelligence and whole genome sequencing to detect unique patterns of DNA fragmentation in the blood of patients with cancer. These analyses are performed through simultaneous examination of millions of DNA sequences using machine learning to identify tumor-specific abnormalities.
In our passionate pursuit to radically improve health outcomes, we serve humanity when we:
Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.
Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product – we aim to disrupt the path of cancer for all – no matter geography or socioeconomic class 
Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us–win. We show up with empathy, humility, and integrity at every step of the journey.
About the Role
The Director, Software Quality and Regulatory Compliance, ensures that the software development at Delfi Diagnostics follows applicable procedures and complies with applicable regulations.  This position is responsible for developing and overseeing strategies for efficiently meeting regulatory needs, refining processes and work instructions for regulated software development, managing software content for regulatory submissions, and representing the software function during audits and inspections.
 

What you’ll do

  • Develop the software design control strategy and SDLC process for software development that efficiently meets regulatory needs
  • Develop processes and establish templates for generation of software related content for regulatory submissions
  • Develop software and cybersecurity content for regulatory submissions
  • Verify software development processes and deliverables
  • Develop SOPs and work instructions for software development processes
  • Develop efficient strategies for verifying and validating software systems 
  • What you’ll have accomplished 12 months from now

  • Managed content for regulatory software submissions, including non-product validation and cybersecurity analysis
  • Define and drive validation activities for software systems used for medical device development and operation
  • Define and drive validation activities for software systems used to operate a clinical laboratory
  • Developed and optimized processes for regulated software development
  • What you’ll bring to DELFI

  • Extensive experience with applicable regulations in US IVD, CLIA/CAP, NYS DOH, and ex-US contexts
  • Experience developing and maintaining software development processes and procedures
  • Experience developing, writing, and managing content for regulatory filings
  • Understanding of software validation approaches for GxP, IVD, and CLIA/CAP contexts
  • Exposure to regulatory treatment of cybersecurity requirements and analysis
  • 10 years experience in a software quality role
  • Bachelor’s degree in a scientific or quality/regulatory area
  • Experience with IVDD/IVDR regulations (preferred)
  • GDPR, Security, and Ex-US regulatory understanding in an IVD context (preferred)
  • Understanding of Next Generation sequencing technologies and assays (preferred)
  • An equal opportunity employer
    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.