Lead Technology Product Manager - Healthcare Regulatory Initiatives

Wolters Kluwer•Waltham, MA

5d•$145,500 - $203,900

About The Position

Regulatory Initiatives Product Manager Wolters Kluwer is a global leader in professional information and software solutions, trusted by clinicians and healthcare organizations worldwide. Our Clinical Decision Support Provider (CDSP) division delivers evidence-based innovations that empower providers to make informed decisions at the point of care. UpToDate Expert AI is a market-leading health AI platform transforming clinical decision-making through cutting-edge technology and deep medical intelligence. Our solutions are rapidly becoming the gold standard for AI-powered clinical intelligence. We operate in a fast-paced, mission-driven environment where bold thinking and collaboration shape the future of healthcare. This is a product management role focused on integrating regulatory and compliance considerations into product strategy and development. It is not a Regulatory Affairs, PRRC, or Quality role and does not carry regulatory sign-off accountability . The role works in close partnership with Regulatory Affairs, Quality, Legal, Privacy, and Security teams who maintain regulatory authority.

Requirements

4–7 years in product management or a regulatory-adjacent role in healthcare software/digital health.
Some 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.

Nice To Haves

Experience working with Notified Bodies, auditors, enterprise healthcare customers, or health system IT/security teams.
Ability to bridge regulatory expectations with product development practices.
Strong documentation, organizational, and project management abilities.

Responsibilities

Regulatory Strategy & Planning Translate regulatory and compliance guidance into product strategy impacts in partnership with Regulatory Affairs.
Maintain a regulatory-informed product roadmap aligned with business objectives and market expansion plans.
Monitor upcoming regulatory changes and assess implications for product features, architecture, deployment, and market access.
Compliance Integration into Product Development Collaborate with engineering, QA, Clinical, and RA teams to ensure regulatory needs are reflected in product requirements.
Support efficient processes that balance innovation with compliance expectations.
Documentation Support & Audit Preparation Contribute product inputs to regulatory submissions and technical documentation.
Support audit preparation by ensuring key product documents and design evidence are complete and accessible.
Risk & Post-Market Support Assist with product risk assessments and incorporate mitigations into product decisions.
Collaborate with Quality on post-market surveillance inputs and customer trend analysis.
Commercial & Market Access Enablement Partner with commercial, regional, and market access teams to ensure new market launches consider product-specific regulatory and compliance requirements.
Provide product guidance for go-to-market materials, customer conversations, and compliance-related positioning, in collaboration with RA and Legal.
Customer, Partner, & Enterprise Engagement Provide product-level regulatory/compliance guidance for new market launches.
Support enterprise customers during onboarding, security/compliance reviews, RFPs, and due diligence.