Vice President of Product Software

Job Summary

A company is looking for a Vice President, Product Software.

Key Responsibilities

• Lead cross-functional teams in executing the software development lifecycle for regulated product development
• Collaborate with teams to integrate bioinformatic and software innovations into diagnostic tools and workflows
• Develop and implement software validation strategies ensuring compliance with regulatory standards

Required Qualifications

• Bachelor's or MS in Engineering, Computer Science, or a related field
• 10+ years of experience in the medical device industry with knowledge of software validation practices
• Deep understanding of FDA regulations and compliance requirements for medical devices
• Experience with risk management processes and tools throughout the software development process
• Proven track record of direct interaction with regulatory bodies such as the FDA