As a Junior Regulatory Affairs Engineer, you bridge technical product development, quality management, and global regulations for advanced image-guided therapy equipment at Philips. You build regulatory strategies to bring medical innovations safely and efficiently to market. Your daily impact:
- Develop and execute regulatory strategies for market entry in the US, EU, and Canada.
- Translate FDA guidelines and European MDE/CE regulations into practical technical solutions.
- Prepare international registration dossiers, including clinical evaluations.
- Evaluate product, software, packaging, and supplier changes. • Conduct risk assessments, manage incidents via Trackwise, and support external audits.
