This role is a highly visible global leadership position at the intersection of clinical development, oncology science, regulatory strategy, and commercialization readiness
Job Summary
This role is a highly visible global leadership position at the intersection of clinical development, oncology science, regulatory strategy, and commercialization readiness.
You will shape how innovative Class IIb/III medical technologies are positioned within evolving oncology treatment paradigms.
Join a team of passionate, collaborative people who support each other, challenge one another, and innovate together.
Matching Summary
This role is a highly visible global leadership position at the intersection of clinical development, oncology science, regulatory strategy, and commercialization readiness.
Skills & Requirements
Must-have
Class III medical devices
global regulatory strategy
FDA and EMA engagement
clinical study design
regulatory documentation
cross-functional collaboration
Nice-to-have
oncology product experience
software as a medical device knowledge
digital media regulatory review
matrixed global organization experience
Key Requirements
Master’s degree in life sciences or related field
10–12 years of regulatory affairs experience
5 years in a leadership role
Experience with IDEs, PMAs, CE Mark submissions
Proven experience engaging with FDA and global regulatory authorities