Samd And Ivd Principal Manager

Takeda UK

Lexington, MA, United States
Base: $111,800.00 - $175,670.00; bonus/equity: not...
Experience in quality assurance
Knowledge of iso regulations
Risk management documentation expertise
The SaMD and IVD Principal Manager is responsible for executing activities within the Device Quality function for software medical devices and in vitro diagnostics

Job Summary

  • The SaMD and IVD Principal Manager is responsible for executing activities within the Device Quality function for software medical devices and in vitro diagnostics.
  • This role ensures compliance with quality and regulatory standards while providing oversight for inspections and regulatory submissions.
  • Takeda offers a competitive salary range and comprehensive benefits including medical, dental, and paid vacation.

Matching Summary

The SaMD and IVD Principal Manager is responsible for executing activities within the Device Quality function for software medical devices and in vitro diagnostics.

Salary

Base: $111,800.00 - $175,670.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision insurance

Skills & Requirements

Must-have

  • Experience in Quality Assurance
  • Knowledge of ISO regulations
  • Risk management documentation expertise

Nice-to-have

  • Collaboration with cross-functional teams
  • Experience in biotech/device industry
  • Familiarity with digital health solutions

Key Requirements

  • Bachelor’s degree in Engineering
  • At least 5 years of experience
  • Extensive knowledge of international regulations

Work Rights

Not specified

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