Vice President, Product Software - Remote

Overview

The Vice President, Product Software will lead the product technology lifecycle and will be responsible for driving compliance and implementing the strategic vision for regulated software products and services critical to Foresight Diagnostics' mission.

In Short

• Lead the product technology lifecycle for regulated software products.
• Collaborate with cross-functional teams to integrate innovations into diagnostic tools.
• Ensure compliance with regulatory standards throughout the software lifecycle.
• Oversee risk management activities and maintain detailed documentation.
• Prepare technical documentation and regulatory submissions for FDA interactions.
• Manage the product software backlog and prioritize features based on user needs.
• Drive cross-functional initiatives aligned with organizational goals.
• Provide technical guidance to the product technology team.
• Stay updated with advancements in bioinformatics and software for medical devices.
• Act as a subject matter expert in internal and external discussions.

Requirements

• Bachelor’s or MS in Engineering, Computer Science, or a related field.
• 10+ years of experience in the medical device industry.
• Strong knowledge of software validation practices and quality systems.
• Deep understanding of FDA regulations for medical devices.
• Experience with cybersecurity compliance in software solutions.
• Proven track record with regulatory bodies like the FDA.
• Strong interpersonal and communication skills.
• History of mentoring and coaching team members.
• Adaptability to fast-paced environments.

Benefits

• Salary of $275,000 with bonus and equity offerings.
• Paid vacation and sick time.
• Parental leave (if applicable).
• Medical, dental, vision, life, and disability coverage.
• Flexible spending accounts.
• 401k with company match.
• Opportunities for professional development and upward mobility.
• Work on high-impact problems.
• Equal opportunity employer.