Job Details

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.

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.

Qualifications

• 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.

Preferred Skills

• 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.

Our Interview Practices

To maintain a fair and genuine hiring process, we kindly ask that all candidates participate in interviews without the assistance of AI tools or external prompts. Our interview process is designed to assess your individual skills, experiences, and communication style. We value authenticity and want to ensure we're getting to know you-not a digital assistant. To help maintain this integrity, we ask to remove virtual backgrounds and include in-person interviews in our hiring process. Please note that use of AI-generated responses or third-party support during interviews will be grounds for disqualification from the recruitment process.

Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process.

Compensation:
$128,900.00 - $226,050.00 USD

This role is eligible for Bonus.

Compensation range listed is based on primary location of the position. Actual base salary offer is influenced by a wide array of factors including but not limited to skills, experience and actual hiring location. Your recruiter can share more information about the specific offer for the job location during the hiring process.

Additional Information:

Wolters Kluwer offers a wide variety of competitive benefits and programs to help meet your needs and balance your work and personal life, including but not limited to: Medical, Dental, & Vision Plans, 401(k), FSA/HSA, Commuter Benefits, Tuition Assistance Plan, Vacation and Sick Time, and Paid Parental Leave. Full details of our benefits are available upon request.