AVP, Global Regulatory Strategy (AI)

TL;DR

AVP, Global Regulatory Strategy (AI/Medtech): Developing and implementing global regulatory strategies for an AI-powered, cloud-native radiology platform with an accent on FDA, EU MDR, and international filings. Focus on scaling SaMD compliance programs, overseeing AI/ML-enabled device submissions, and managing relationships with global regulatory authorities.

Location: Remote (Must be based in the US)

Salary: $200,000–$250,000

Company

hirify.global is a leading physician-led radiology practice in the U.S. transforming the field through technology and clinical innovation.

What you will do

• Develop global regulatory strategies for AI-powered platform launches and foundation models.
• Lead submissions for FDA (510(k)/De Novo/PMA), EU MDR (CE marking), and other international bodies (Health Canada, PMDA, UKCA, TGA, SFDA).
• Act as the primary liaison with FDA and Notified Bodies for inquiries, audits, and negotiations.
• Guide cross-functional teams on design controls, ISO 14971, IEC 62304, and cybersecurity requirements.
• Scale compliance programs for SaMD products, including SOC 2 and HITRUST readiness.
• Oversee post-market surveillance, vigilance reporting, and change assessments for deployed products.

Requirements

• 10+ years of experience in medical device regulatory affairs.
• 5+ years focused on Software as a Medical Device (SaMD) or diagnostic imaging software.
• Proven success leading global submissions (FDA clearances, CE marking under MDR).
• Experience scaling ISO 13485-compliant quality management systems.
• Deep knowledge of FDA 21 CFR Part 820, IEC 62304, and ISO 14971.
• Must be eligible for employment via E-Verify in the USA.

Nice to have

• Experience with AI/ML-specific risk assessments and Predetermined Change Control Plans.
• SOC 2 Type I/II audit leadership experience.
• Direct experience with PACS or RIS medical imaging software.

Culture & Benefits

• Competitive total rewards package including health and wellness coverage.
• 401k benefits and generous PTO plans with paid holidays.
• Flexible remote schedules.
• Annual discretionary bonuses and career growth opportunities.
• Certified as a Great Place to Work for five consecutive years.