At IDE, we build better futures. We create meaningful medtech ventures that save lives and improve quality of life. We work at the intersection of engineering, design, and commercial thinking and we love solving complex problems together.
We’re looking for a Senior Regulatory Affairs Specialist to assist the Director in regulatory strategy across innovative medical device programs. You’ll help guide products from concept to commercialisation, shape regulatory pathways, and strengthen IDE’s Quality Management System
If you enjoy navigating complexity, influencing outcomes, and helping teams bring impactful technologies to market, this role will feel like home.
What You’ll do
- Assist in regulatory strategy across medical device development projects
- Prepare global submissions for Australia, USA, and Europe
- Ensure compliance with ISO 13485, EU MDR, and 21 CFR 820
- Develop technical documentation and quality records
- Facilitate risk management including FMEA and Hazard Analysis
- Assist with regulatory and quality requirements
- Improve IDE’s Quality Management system and regulatory capability
