Drug device combination product regulatory requirements
Medical device and drug-device combination product quality requirements
Our Global Device Development organisation is focused on the design, development, and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe
Job Summary
Our Global Device Development organisation is focused on the design, development, and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe.
Every member of our team is dedicated to creating better health for a better world, one person at a time.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Matching Summary
Our Global Device Development organisation is focused on the design, development, and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe.
Skills & Requirements
Must-have
FDA, EU and ISO standards, regulations
Drug Device Combination Product regulatory requirements
Medical Device and Drug-Device Combination Product quality requirements
Device design controls in accordance with ISO 13485
Software as a Medical Device (SaMD) expertise
Technical Regulatory strategy and content development
Nice-to-have
Collaborative culture
Courage and resilience
People management experience
Impact on lives of others
Key Requirements
Bachelor's degree in a scientific/engineering discipline
Proven experience in pharmaceutical and/or medical device development
Advanced knowledge of global Medical Device and Drug-Device Combination Product regulatory requirements
Knowledge of global Medical Device and Drug-Device Combination Product quality requirements
Demonstrable experience in multi-disciplinary teams