Offer summary
Qualifications:
Master’s degree or equivalent required, 8+ years in Regulatory Affairs, Experience with FDA regulatory submissions, Knowledge of medical device regulations, Familiarity with Class II/III devices.Key responsabilities:
- Ensure safe market access for products
- Compile registration dossiers and advise teams
- Build strategic relationships with external stakeholders
- Lead cross-functional partnerships within the company
- Support business through regulatory risk assessments