Lead Samd Technical Program Manager

Wolters Kluwer N.V

Multiple Locations
Base: $128,900.00 - $226,050.00 usd; bonus: eligib...
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Software as a medical device (samd) development
Fda and eu mdr regulatory compliance
Iso 13485 and iec 62304 standards
** Wolters Kluwer N.V. is seeking a Lead SaMD Technical Program Manager to oversee the development and delivery of Software as a Medical Device (SaMD) products. The role requires strong leadership, project management skills, and experience with regulatory standards while promoting agile methodologies within cross-functional teams. **

Job Summary

  • The role drives the development and delivery of Software as a Medical Device products while ensuring strict compliance with global regulatory standards.
  • Candidates must possess 9+ years of experience in technical program management within regulated medical software environments using agile practices.
  • The position offers a competitive salary range of $128,900.00 to $226,050.00 USD along with comprehensive benefits including medical, dental, vision, and 401(k).

Matching Summary

Match Score: 75

** Wolters Kluwer N.V. is seeking a Lead SaMD Technical Program Manager to oversee the development and delivery of Software as a Medical Device (SaMD) products. The role requires strong leadership, project management skills, and experience with regulatory standards while promoting agile methodologies within cross-functional teams. **

Salary

Base: $128,900.00 - $226,050.00 USD; Bonus: Eligible for Bonus; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Tuition Assistance

Skills & Requirements

Must-have

  • Software as a Medical Device (SaMD) development
  • FDA and EU MDR regulatory compliance
  • ISO 13485 and IEC 62304 standards
  • Agile and Lean engineering practices
  • Design control and risk management
  • Cross-functional team leadership

Nice-to-have

  • Cybersecurity compliance for medical software
  • AI/ML compliance experience
  • Process automation implementation
  • Executive stakeholder engagement
  • Post-market surveillance expertise

Key Requirements

  • Bachelor's degree in engineering or computer science
  • 9+ years of SaMD or regulated medical software experience
  • Hands-on experience with design control and technical documentation
  • Demonstrated experience working under ISO 13485 and 21 CFR 820 QMS
  • Experience with eQMS tooling for SaMD project management

Work Rights

Not specified

Tailored Resume

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