Senior Regulatory Affairs Specialist

Wolters Kluwer

Base: $85,600.00 - $149,400.00 usd; bonus: eligibl...
Onsite
5-7+ years regulatory affairs experience
Fda 510(k) and de novo submission leadership
Eu mdr and global medical device regulations expertise
Wolters Kluwer is seeking a Senior Regulatory Affairs Specialist to lead regulatory efforts for their Software as a Medical Device (SaMD) portfolio globally. The ideal candidate will have extensive experience in regulatory affairs, particularly with FDA and EU submissions, and a strong understanding of medical device regulations

Job Summary

  • This role serves as the regulatory lead expert supporting the expansion of the Software as a Medical Device portfolio across global markets.
  • The successful candidate will guide product teams through compliant design and commercialization while representing the company in high-stakes regulatory interactions.
  • Wolters Kluwer offers competitive benefits including medical, dental, vision plans, 401(k), and paid parental leave to support work-life balance.

Matching Summary

Match Score: 85

Wolters Kluwer is seeking a Senior Regulatory Affairs Specialist to lead regulatory efforts for their Software as a Medical Device (SaMD) portfolio globally. The ideal candidate will have extensive experience in regulatory affairs, particularly with FDA and EU submissions, and a strong understanding of medical device regulations.

Salary

Base: $85,600.00 - $149,400.00 USD; Bonus: Eligible for Bonus; Benefits: Medical, Dental, Vision, 401(k), Tuition Assistance

Skills & Requirements

Must-have

  • 5-7+ years regulatory affairs experience
  • FDA 510(k) and De Novo submission leadership
  • EU MDR and global medical device regulations expertise
  • Software standards IEC 62304 and ISO 14971 knowledge
  • Primary author of technical documentation and filings

Nice-to-have

  • RAC Global or EU certification preferred
  • ISO 13485 and PMP certifications preferred
  • Cybersecurity expectations familiarity
  • Clinical evaluation framework knowledge
  • Electronic QMS systems proficiency

Key Requirements

  • Bachelor's degree in Life Sciences, Engineering, or Regulatory Science
  • Advanced degree preferred
  • RAC certification preferred
  • ISO 14971 certification preferred
  • ISO 13485 certification preferred
  • PMP certification preferred

Work Rights

Not specified

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