Lead Technology Product Manager - Healthcare Regulatory Initiatives

Wolters Kluwer N.V

Waltham, MA, United States
Base: $128,900.00 - $226,050.00 usd; bonus: eligib...
Onsite
4-7 years product management experience
Healthcare software or digital health background
Understanding of fda, eu mdr/ivdr, hipaa, gdpr
Wolters Kluwer is seeking a Lead Technology Product Manager for their Healthcare Regulatory Initiatives in Waltham, MA. This role focuses on integrating regulatory compliance into product strategy for AI-driven clinical decision support tools, requiring collaboration with various teams to ensure regulatory adherence while fostering innovation

Job Summary

  • This role focuses on integrating regulatory and compliance considerations into product strategy without carrying regulatory sign-off accountability.
  • The position requires translating regulatory guidance into product roadmap impacts while collaborating closely with Regulatory Affairs, Quality, Legal, and Security teams.
  • Wolters Kluwer offers competitive benefits including medical, dental, vision plans, 401(k), and paid parental leave.

Matching Summary

Match Score: 85

Wolters Kluwer is seeking a Lead Technology Product Manager for their Healthcare Regulatory Initiatives in Waltham, MA. This role focuses on integrating regulatory compliance into product strategy for AI-driven clinical decision support tools, requiring collaboration with various teams to ensure regulatory adherence while fostering innovation.

Salary

Base: $128,900.00 - $226,050.00 USD; Bonus: Eligible; Benefits: Medical, Dental, Vision, 401(k), Tuition Assistance

Skills & Requirements

Must-have

  • 4-7 years product management experience
  • Healthcare software or digital health background
  • Understanding of FDA, EU MDR/IVDR, HIPAA, GDPR

Nice-to-have

  • Experience with AI/ML-driven products or SaMD
  • Familiarity with Notified Bodies and auditors
  • Strong cross-functional collaboration skills

Key Requirements

  • 4–7 years in product management or regulatory-adjacent role
  • Experience with global healthcare regulations (FDA, HIPAA, GDPR)
  • Strong documentation and project management abilities

Work Rights

Not specified

Tailored Resume

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