Stellenbeschreibung:

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.

Requirements

• Bachelor’s or Master’s degree in Engineering, Computer Science, or related field.
• 10+ years of experience in the medical device industry, with deep knowledge of software validation practices, regulatory compliance, and quality systems (e.g., ISO 13485, IEC 62304).
• Proven experience interacting with regulatory bodies such as the FDA (510(k), PMA, Breakthrough Device Designation).
• Expertise in software risk management, cybersecurity, HIPAA compliance, and secure software development.
• Strong leadership skills with a track record of mentoring and developing high-performing teams.
• Excellent communication and interpersonal skills to work effectively across cross-functional teams.
• Adaptable to a fast-paced, dynamic environment with shifting priorities.

Benefits

• Competitive salary: $275,000, plus bonus and equity opportunities.
• Comprehensive health benefits including medical, dental, vision, life, and disability coverage.
• Paid vacation, sick time, and parental leave.
• Flexible spending accounts and 401(k) plan with company match.
• Opportunity for professional growth, high-impact contributions, and career advancement.
• Remote or hybrid work flexibility based in Boulder, Colorado, or elsewhere in the U.S.


Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest!

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