About this role
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:
$127,000.00 - $222,650.00 USDThis 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.
Other facts
About Wolters Kluwer
Wolters Kluwer (EURONEXT: WKL) is a global leader in information, software solutions, and services for professionals in healthcare; tax and accounting; financial and corporate compliance; legal and regulatory; corporate performance and ESG. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with technology. Wolters Kluwer reported 2024 annual revenues of €5.9 billion. The group serves customers in over 180 countries, maintains operations in over 40 countries, and employs approximately 21,000 people worldwide. The company is headquartered in Alphen aan den Rijn, the Netherlands.
Equal Opportunity Employer
To ensure we continue to drive innovation that enables us to develop products and services to best serve our customers, we cultivate a workplace culture rooted in mutual respect, bringing forward insights from a wide range of backgrounds, perspectives, and experiences. We are also committed to complying with laws requiring equal opportunity in hiring, promotion, and other employment decisions.
All qualified applicants will receive consideration without regard to race, color, religion, sex (including pregnancy, gender identity, transgender status, and sexual orientation), national origin, disability, age, genetic information, veteran status, or any other characteristic protected by applicable law, and we do not tolerate discrimination on any of these bases.
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- Apply only via our secure Workday hub on our Careers page.
- Our recruiters never ask for banking info or payments.
- We don't use public email accounts (e.g., Hotmail, Yahoo, Gmail).
Report suspected fraud: [email protected]. If you've made a payment, contact local authorities.
Read more here - https://careers.wolterskluwer.com/en/recruitment-fraud-alert
What you'll do
- The Lead Technology Product Manager will translate regulatory and compliance guidance into product strategy and maintain a regulatory-informed product roadmap. They will collaborate with various teams to ensure regulatory needs are integrated into product development and support audit preparations.
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