Location: Remote (Preference for candidates in or near U.S. Eastern Time)
Employment Type: Full-Time
Salary Range: USD $3,800 – $4,000 per month
We are seeking an experienced Software Developer with a strong focus on regression testing and validation to ensure the reliability and compliance of business-critical systems.
This role is integral to developing and maintaining internal applications within the Microsoft 365 ecosystem, supporting teams in clinical, regulatory, and operational functions.
The ideal candidate combines deep technical expertise in the Microsoft stack with a disciplined testing mindset, ensuring every solution meets GxP, FDA, and data integrity requirements.
Own the regression testing process — design, implement, and execute regression test suites to validate stability, performance, and compliance of applications following every release.
Develop scalable backend services using .NET, integrating with SQL and Microsoft Dataverse.
Automate workflows and validation checkpoints using Power Automate to ensure accuracy and compliance in business and GxP processes.
Participate in manual and automated testing, debugging, and validation of applications to ensure reliability and zero data deviation.
Optimize web applications for data integrity, security, and compliance with FDA 21 CFR Part 11, HIPAA, and GDPR.
Collaborate closely with IT, Clinical Operations, Regulatory, and Quality teams to deliver compliant and traceable software releases.
Write clean, testable code with a strong emphasis on unit and regression test coverage to support continuous integration and validation.
Prepare technical documentation, validation protocols, and regression testing records for audit readiness.
Provide ongoing technical support and troubleshooting while maintaining strict version control and release documentation.
Bachelor’s degree in Computer Science, Information Technology, or related field.
3+ years of experience in software development, ideally in a regulated environment (life sciences, healthcare, defense, or aerospace).
Extensive hands-on experience with regression testing — designing, maintaining, and executing regression test cases in complex applications.
Strong proficiency in SQL, ASP.NET, and Microsoft technologies including Dataverse, Power BI, and Entra AD.
Understanding of software validation, data integrity principles, and GxP regulations.
Familiarity with clinical operations workflows and terminology.
Experience with Veeva Vault, IQVIA, TrialKit, or Medidata Rave applications.
Hands-on development experience in PowerApps, Smartsheet, and SharePoint (custom workflows, forms, and automation).
Background in clinical trials, regulatory affairs, or quality systems.
Microsoft certifications (Power Platform, Azure, .NET) are a plus.
Preference for candidates aligned with the U.S. Eastern Time zone for seamless collaboration.