Vice President, Product Software (remote - US) - Remote Eligible

Vice President, Product Software

This position is posted by Jobgether on behalf of Foresight Diagnostics Inc. We are currently looking for a Vice President, Product Software in United States.

This role offers the opportunity to lead the software product function for regulated medical technologies, driving the development, compliance, and lifecycle management of mission-critical software solutions. The Vice President, Product Software will oversee cross-functional teams, ensuring regulatory adherence, quality, and innovation in software that supports advanced diagnostics. The role combines technical leadership, strategic vision, and regulatory expertise to influence product strategy, deliver validated software solutions, and interact directly with regulatory authorities. Success in this position will directly impact product safety, patient outcomes, and the company's position as a leader in molecular diagnostics. The environment is fast-paced, highly collaborative, and focused on high-impact contributions.

Accountabilities:

• Lead the product software lifecycle, ensuring adherence to regulatory requirements, software development processes, and quality standards.
• Collaborate with PMO, Regulated Assay Development, Regulatory Affairs, Software Systems Engineering, Operations, and Quality to integrate software and bioinformatics innovations into diagnostic tools.
• Oversee software validation, verification, and risk management strategies, ensuring compliance with FDA, ISO, IEC 62304, and other relevant standards.
• Manage the product software backlog, prioritizing features and enhancements based on roadmap, user needs, and business value.
• Prepare technical documentation, regulatory submissions (510(k), PMA), and participate in interactions with regulatory authorities.
• Provide technical mentorship, strategic guidance, and career development support to the product technology team.
• Act as a subject-matter expert representing software product strategy in internal and external collaborations.