Regulatory Affairs Specialist

Tempus

Chicago, Illinois, United States
Base: $90,000-$120,000 (illinois); bonus/equity: i...
Experience with complex medical devices
Knowledge of fda submission processes
Understanding of iso 13485 and 21 cfr 820
The role involves developing and leading global regulatory strategies to support business objectives for personalized medicine

Job Summary

  • The role involves developing and leading global regulatory strategies to support business objectives for personalized medicine.
  • Candidates will work closely with scientists, engineers, clinicians, and legal teams to advance regulated medical devices.
  • Tempus offers a full range of benefits including incentive compensation and restricted stock units depending on the position.

Matching Summary

The role involves developing and leading global regulatory strategies to support business objectives for personalized medicine.

Salary

Base: $90,000-$120,000 (Illinois); Bonus/Equity: Incentive compensation and restricted stock units; Benefits: Medical and other benefits

Skills & Requirements

Must-have

  • Experience with complex medical devices
  • Knowledge of FDA submission processes
  • Understanding of ISO 13485 and 21 CFR 820

Nice-to-have

  • Experience in startup-like environment
  • Strong cross-functional team leadership
  • Ability to identify creative solutions

Key Requirements

  • PhD preferred
  • Minimum of 2+ years Regulatory Affairs experience
  • Experience with PMA, 510(k), De Novo, and IDE requirements

Work Rights

Not specified

Tailored Resume

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