Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

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.

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:

• Bachelor's 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

Compensation: $85,600.00 - $149,400.00 USDThis role is eligible for Bonus.

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.