Samd And Ivd Principal Manager

Takeda UK

Lexington, MA, US
Base: $116,000.00 - $182,270.00; bonus/equity: sho...
Not specified
Iec 62304 compliance expertise
Iso 13485 and iso 14971 knowledge
Medical device quality assurance experience
Takeda UK is seeking a SaMD and IVD Principal Manager in Lexington, MA, who will oversee quality and regulatory compliance for software medical devices and in vitro diagnostics. The ideal candidate should have extensive experience in Quality Assurance within the medical device industry, with strong knowledge of international regulations and a collaborative mindset

Job Summary

  • The role is responsible for executing quality activities across the entire product lifecycle for software medical devices and IVDs.
  • Candidates must ensure compliance with global regulations including MDR, MDSAP, and IEC standards while leading risk management deliverables.
  • Takeda offers a competitive salary range of $116,000 to $182,270 along with comprehensive benefits including 401(k) matching and paid time off.

Matching Summary

Match Score: 85

Takeda UK is seeking a SaMD and IVD Principal Manager in Lexington, MA, who will oversee quality and regulatory compliance for software medical devices and in vitro diagnostics. The ideal candidate should have extensive experience in Quality Assurance within the medical device industry, with strong knowledge of international regulations and a collaborative mindset.

Salary

Base: $116,000.00 - $182,270.00; Bonus/Equity: Short-term and/or long-term incentives eligible; Benefits: Medical, dental, vision, 401(k), paid vacation, sick time

Skills & Requirements

Must-have

  • IEC 62304 compliance expertise
  • ISO 13485 and ISO 14971 knowledge
  • Medical device quality assurance experience
  • Risk management documentation skills
  • Regulatory submission support

Nice-to-have

  • Biotech or device industry background
  • Digital health solutions familiarity
  • Cross-functional team collaboration
  • Process improvement initiatives
  • Advanced degree preferred

Key Requirements

  • Bachelor's degree in Engineering or equivalent
  • 5+ years QA/QE experience in medical devices
  • Experience with commercial development and regulatory filings

Work Rights

Not specified

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