Wolters Kluwer · 1 month ago
Lead Technology Product Manager - Healthcare Regulatory Initiatives
USA - Waltham, MA
Full-time
Hybrid
Mid, Senior Level
$127K/yr - $223K/yr
4+ years expWolters Kluwer is a global leader in professional information and software solutions, trusted by clinicians and healthcare organizations worldwide. The role focuses on integrating regulatory and compliance considerations into product strategy and development, collaborating with various teams to ensure that product requirements reflect regulatory needs.
BankingFinanceInformation ServicesInformation TechnologyLegalMobilePublishingSoftware
Responsibilities
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
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
Contribute product inputs to regulatory submissions and technical documentation
Support audit preparation by ensuring key product documents and design evidence are complete and accessible
Assist with product risk assessments and incorporate mitigations into product decisions
Collaborate with Quality on post-market surveillance inputs and customer trend analysis
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
Provide product-level regulatory/compliance guidance for new market launches
Support enterprise customers during onboarding, security/compliance reviews, RFPs, and due diligence
Qualification
Required
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)
Strong cross-functional collaboration and documentation skills
Ability to translate regulatory expectations into practical product decisions
Preferred
Experience with AI/ML-driven products or SaMD preferred
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
Benefits
Medical, Dental, & Vision Plans
401(k)
FSA/HSA
Commuter Benefits
Tuition Assistance Plan
Vacation and Sick Time
Paid Parental Leave
Company
Wolters Kluwer
Wolters Kluwer is an information services company specializing in software solutions and services for the healthcare and legal sectors.
10001+ employees
H1B Sponsorship
Wolters Kluwer has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (94)
2024 (22)
2023 (23)
2022 (10)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.78B2025-06-23Post Ipo Debt· $578.76M
2025-03-13Post Ipo Debt· $542.74M
2024-03-11Post Ipo Debt· $655.84M
Leadership Team
Jason Marx
CEO, Wolters Kluwer Tax & Accounting
Nancy McKinstry
CEO
Recent News
thefly.com
2026-01-12
2026-01-11
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