Offer summary
Qualifications:
Master’s degree or equivalent required, 8+ years of Regulatory Affairs experience, Knowledge of FDA regulatory submissions, Experience with medical devices, SaMD, AI, Familiarity with global regulatory strategies.Key responsabilities:
- Ensure safe and effective product market access
- Compile registration dossiers and submissions
- Provide regulatory risk assessments support
- Build relationships with external stakeholders
- Lead cross-functional partnerships for compliance