Deep knowledge of clsi ivdr fda iso nmpa regulations
Agile safe and traditional project management methodologies
Roche is seeking an Assay Development Lead to manage the execution of complex projects related to IVD assay development in a hybrid work environment. The ideal candidate will have significant experience in life sciences or engineering, specifically within the IVD or Medical Device industry, and will be responsible for leading cross-functional teams to ensure compliance and project success
Job Summary
The role involves driving the day-to-day execution of the Lumira Assay development roadmap to translate product vision into prioritized work packages.
You will orchestrate a complex ecosystem comprising R&D, Operations, Quality, Regulatory, and Clinical disciplines to ensure solutions are robust and compliant.
Roche fosters a culture where personal expression is embraced, allowing employees to thrive both personally and professionally while preventing and curing diseases.
Matching Summary
Match Score: 85
Roche is seeking an Assay Development Lead to manage the execution of complex projects related to IVD assay development in a hybrid work environment. The ideal candidate will have significant experience in life sciences or engineering, specifically within the IVD or Medical Device industry, and will be responsible for leading cross-functional teams to ensure compliance and project success.
Skills & Requirements
Must-have
IVD or Medical Device industry experience
Deep knowledge of CLSI IVDR FDA ISO NMPA regulations
Agile SAFe and traditional project management methodologies
Cross-functional matrix leadership skills
Platform-based Near Patient Care assay development
Nice-to-have
Proactive scenario planning and risk management
Culture of high-impact collaboration
Transparent data-driven communication to stakeholders
Continuous improvement of development processes
Ability to solve complex technical execution problems
Key Requirements
Significant experience in life sciences or engineering
Proven track record delivering complex IVD projects from definition to launch
Practical experience navigating regulatory requirements including CLSI IVDR FDA ISO NMPA