Senior Regulatory Affairs Specialist

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:RegulatorySupport 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 filingsAdvise Product leadership on regulatory pathways, classification, predicate selection, clinical evidence needs, and market expansion opportunitiesSupport regulatory interactions with FDA, Notified Bodies, and other competent authoritiesStandards & ComplianceEnsure 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 managementOversee regulatory aspects of software validation, cybersecurity documentation, clinical evaluation, and risk managementTechnical Documentation & LabelingOwn Regulatory Product Files and Technical DocumentationEnsure audit-readiness of DHFs, cybersecurity files, clinical evaluations, and post-market surveillance documentationReview and approve labeling, claims, and marketing materialsRegulatory Intelligence & Risk MitigationMonitor evolving regulatory landscapes and translate changes into strategic guidanceConduct gap assessments and lead remediation initiativesEvaluate regulatory risks and provide recommendations to leadershipCross-Functional LeadershipServe as primary regulatory partner to Product, Engineering, Quality, Clinical, Legal, and MarketingSupport clinical evidence strategies, risk analyses, verification/validation, and post-market surveillanceAudits & InspectionsSupport regulatory preparation for internal audits, FDA inspections, and Notified Body auditsSupport evidence gathering and CAPA remediationTraining, Mentorship & External RepresentationProvide regulatory training to internal teamsRepresent the company in regulatory workgroups and industry forumsPreferred Competencies:RAC (Global) or RAC (EU) certification preferredISO 14971 certification preferredISO 13485 certification preferredPMP certification preferredKnowledge of cybersecurity expectationsFamiliarity with clinical evaluation frameworksProficiency with electronic QMS systemsRequired Qualifications:Bachelor's degree in Life Sciences, Engineering, or Regulatory Science; advanced degree preferred5–7+ years of regulatory affairs experience in SaMD (preferred) or medical deviceDemonstrated success leading FDA 510(k), De Novo, and EU MDR submissionsDeep expertise in SaMD regulations and software standardsStrong communication and project leadership skillsThe 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 PracticesTo 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:$85,600.00 - $149,400.00 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.