TL;DR
Lead Technology Product Manager (Healthcare AI): Integrates regulatory and compliance considerations into healthcare AI product strategy and development with an accent on maintaining a regulatory-informed product roadmap and ensuring compliance integration. Focus on assessing implications of upcoming regulatory changes for product features and assisting with product risk assessments and mitigations.
Location: Hybrid (8 days/month) in Waltham, MA, USA. Applicants may be required to appear onsite.
Salary: $145,500 - $203,900 USD (for CA, CT, CO, DC, HI, IL, MA, MD, MN, NY, RI, WA)
Company
hirify.global is a global leader in professional information and software solutions, with a division delivering evidence-based innovations in clinical decision support and a market-leading health AI platform.
What you will do
- Translate regulatory and compliance guidance into product strategy and maintain a regulatory-informed product roadmap.
- Collaborate with engineering, QA, Clinical, and RA teams to integrate regulatory needs into product requirements.
- Contribute product inputs to regulatory submissions and technical documentation, supporting audit preparation.
- Assist with product risk assessments and incorporate mitigations into product decisions, collaborating on post-market surveillance.
- Partner with commercial, regional, and market access teams for new market launches, addressing product-specific regulatory and compliance.
- Provide product-level regulatory/compliance guidance and support enterprise customers during onboarding and reviews.
Requirements
- 4–7 years in product management or a regulatory-adjacent role in healthcare software/digital health.
- Understanding of global healthcare regulations and frameworks (FDA, EU MDR/IVDR, HIPAA, GDPR).
- Experience with AI/ML-driven products or SaMD preferred.
- Strong cross-functional collaboration and documentation skills.
- Ability to translate regulatory expectations into practical product decisions.
Culture & Benefits
- Work in a fast-paced, mission-driven environment.
- Be part of a team transforming clinical decision-making through cutting-edge technology and deep medical intelligence.
- Environment where bold thinking and collaboration shape the future of healthcare.
- Hiring process designed to assess individual skills without AI tools or external prompts.
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