About the Role: As the Senior Regulatory Affairs Specialist, you will serve as a regulatory lead expert supporting the expansion of our Software as a Medical Device (SaMD) portfolio across global markets. You will guide product teams through compliant design and commercialization and represent the company in high-stakes regulatory interactions. This role is critical as we scale our medical device offerings and strengthen our global regulatory posture.
Responsibilities: Regulatory Support development of global regulatory requirements for new and existing SaMD products (e.g. FDA, EU MDR, UKCA, TGA, Health Canada, MDSAP jurisdictions)
Serve as primary author and owner of major submissions, including 510(k), De Novo requests, CE Technical Documentation, UKCA dossiers, and global regulatory filings
Advise Product leadership on regulatory pathways, classification, predicate selection, clinical evidence needs, and market expansion opportunities
Support regulatory interactions with FDA, Notified Bodies, and other competent authorities
Standards & Compliance Ensure compliance with global medical device regulations and software standards (e.g. 21 CFR Part 820/11, EU MDR 2017/745, IEC 62304, IEC 62366-1, ISO 14971, IEC 82304-1, EU AI Act, etc.)
Partner with Product teams to integrate regulatory requirements into development and lifecycle management
Oversee regulatory aspects of software validation, cybersecurity documentation, clinical evaluation, and risk management
Technical Documentation & Labeling Own Regulatory Product Files and Technical Documentation
Ensure audit-readiness of DHFs, cybersecurity files, clinical evaluations, and post-market surveillance documentation
Review and approve labeling, claims, and marketing materials
Regulatory Intelligence & Risk Mitigation Monitor evolving regulatory landscapes and translate changes into strategic guidance
Conduct gap assessments and lead remediation initiatives
Evaluate regulatory risks and provide recommendations to leadership
Cross-Functional Leadership Serve as primary regulatory partner to Product, Engineering, Quality, Clinical, Legal, and Marketing
Support clinical evidence strategies, risk analyses, verification/validation, and post-market surveillance
Audits & Inspections Support regulatory preparation for internal audits, FDA inspections, and Notified Body audits
Support evidence gathering and CAPA remediation
Training, Mentorship & External Representation Provide regulatory training to internal teams
Represent the company in regulatory workgroups and industry forums
Preferred Competencies: RAC (Global) or RAC (EU) certification preferred
ISO 14971 certification preferred
ISO 13485 certification preferred
PMP certification preferred
Knowledge of cybersecurity expectations
Familiarity with clinical evaluation frameworks
Proficiency with electronic QMS systems
Required Qualifications: Bachelors degree in Life Sciences, Engineering, or Regulatory Science; advanced degree preferred
5-7+ years of regulatory affairs experience in SaMD (preferred) or medical device
Demonstrated success leading FDA 510(k), De Novo, and EU MDR submissions
Deep expertise in SaMD regulations and software standards
Strong communication and project leadership skills
The above statements are intended to describe the general nature and level of work being performed by most people assigned to this job. They are not intended to be an exhaustive list of all duties and responsibilities and requirements.
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 recruitme
At Wolters Kluwer, we excel at creating content solutions for use in a professional context in the fields of health, corporate services, finance, tax, accounting, law, regulation, and education. We are professionals serving professionals and are committed to delivering essential content, software, and services to help our customers make their most critical business decisions. Utilizing the latest in information technology, we ensure that our customers have the solutions they need, when they need them, and in the media best suited to their requirements. When we achieve this, we deliver on our goal of being the market leader in content in context.
Partners in Innovation
Wolters Kluwer professionals are continuously engaged in an ongoing exchange of expertise and ideas with our customers about their work. This partnership in innovation is at the heart of meeting our commitment to the lawyers, doctors, nurses, tax advisors, teachers, and business executives we serve. Knowledge of their professional workflows and the ability to apply emerging technologies to make them more efficient and productive are at the heart of this partnership.
Leading Positions and Brands
Strong market positions are very important to our business strategies at Wolters Kluwer, and we value the leading positions we hold in most of our markets. Across all of our markets, we own strong, enduring brands in North America such as Adis International, Aspen Publishers, Bankers Systems, CCH, ClineGuide, CT Corporation, Kluwer, Facts & Comparisons, IFI Claims, Lippincott Williams & Wilkins, Loislaw, Medi-Span, Ovid Technologiesand Skolar. These brands have promised and delivered high quality information for decades, and we are committed to continuing to do everything necessary to earn, retain, and expand leadership positions in our selected markets.