Regulatory Affairs Manager

Roche UK

Tucson, Arizona, US
Base: $106,100 - $197,000; bonus/equity: discretio...
Ivd regulations
Us and eu regulatory affairs
Regulatory document compilation
The Regulatory Affairs Manager will collaborate with the CLIA-certified Laboratory on the implementation of regulations pertinent to in-vitro diagnostics development within the United States and the European Union (IVDR)

Job Summary

  • The Regulatory Affairs Manager will collaborate with the CLIA-certified Laboratory on the implementation of regulations pertinent to in-vitro diagnostics development within the United States and the European Union (IVDR).
  • You oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs.
  • You have a Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience.

Matching Summary

The Regulatory Affairs Manager will collaborate with the CLIA-certified Laboratory on the implementation of regulations pertinent to in-vitro diagnostics development within the United States and the European Union (IVDR).

Salary

Base: $106,100 - $197,000; Bonus/Equity: Discretionary annual bonus may be available; Benefits: Not specified

Skills & Requirements

Must-have

  • IVD regulations
  • US and EU regulatory affairs
  • Regulatory document compilation
  • Global regulatory submissions
  • Stakeholder management practices
  • Adapt to evolving regulatory environment

Nice-to-have

  • Embrace personal expression
  • Open dialogue and genuine connections
  • Courage to make decisions
  • Build on different perspectives
  • Address and resolve conflict

Key Requirements

  • 3-5 years experience with PhD degree
  • 5-7 years with Masters degree
  • 6-8 years with Bachelor degree
  • Experience with CLIA Regulations
  • Knowledge of European, US, China regulations

Work Rights

Not specified

Tailored Resume

Cover Letter