The role involves collaborating with a CLIA-certified laboratory to implement regulations for in-vitro diagnostics development in the US and EU
Job Summary
The role involves collaborating with a CLIA-certified laboratory to implement regulations for in-vitro diagnostics development in the US and EU.
Candidates will oversee the compilation of complex regulatory submissions and manage global registration plans while interfacing with external stakeholders.
Roche offers a culture that encourages personal expression, open dialogue, and genuine connections where every voice matters.
Matching Summary
The role involves collaborating with a CLIA-certified laboratory to implement regulations for in-vitro diagnostics development in the US and EU.
Salary
Base: $106,100 - $197,000; Bonus/Equity: Discretionary annual bonus available; Benefits: Standard company benefits package included
Skills & Requirements
Must-have
IVD regulatory compliance experience
CLIA regulations knowledge
Global submission dossier compilation
Nice-to-have
Stakeholder management skills
Innovative regulatory strategies
Cross-functional collaboration
Key Requirements
Bachelor's/Master's/PhD in Life Science or related field
3-8 years experience in IVDs, Medical Devices, or Pharma Regulatory Affairs
Knowledge of European, US, China, and international regulations