Senior Regulatory Affairs Specialist

Wolters Kluwer

Multiple Locations
Base: $85,600.00 - $149,400.00 usd; bonus/equity: ...
Onsite
Global regulatory submissions expertise
Samd regulatory compliance
Fda 510(k) and eu mdr submissions
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

Job Summary

  • 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.
  • Wolters Kluwer offers a wide variety of competitive benefits and programs to help meet your needs and balance your work and personal life, including Medical, Dental, & Vision Plans, 401(k), FSA/HSA, Commuter Benefits, Tuition Assistance Plan, Vacation and Sick Time, and Paid Parental Leave.
  • This role is critical as we scale our medical device offerings and strengthen our global regulatory posture.

Matching Summary

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.

Salary

Base: $85,600.00 - $149,400.00 USD; Bonus/Equity: Eligible for Bonus; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Commuter Benefits, Tuition Assistance, Paid Leave

Skills & Requirements

Must-have

  • Global regulatory submissions expertise
  • SaMD regulatory compliance
  • FDA 510(k) and EU MDR submissions
  • Regulatory product file ownership
  • Cross-functional regulatory leadership
  • Regulatory risk assessment and mitigation

Nice-to-have

  • Regulatory training and mentorship
  • Knowledge of cybersecurity standards
  • Experience with electronic QMS systems
  • Participation in regulatory workgroups
  • Clinical evaluation framework familiarity

Key Requirements

  • Bachelor's degree in Life Sciences, Engineering, or Regulatory Science
  • 5–7+ years regulatory affairs experience in SaMD or medical device
  • RAC (Global) or RAC (EU) certification preferred
  • ISO 14971, ISO 13485, PMP certifications preferred
  • Demonstrated success leading FDA 510(k), De Novo, and EU MDR submissions

Work Rights

Not specified

Tailored Resume

Cover Letter