Ide Group

Senior Regulatory Affairs Specialist | MedTech • ISO 13485 • Global Submissions

About IDE Group

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.

The Opportunity

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 commercialization, 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

• 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

What You Bring

• A proactive, solutions-focused approach with the confidence to independently investigate issues, identify the right information, and drive outcomes with minimal direction
• An ability to think beyond established processes, solve complex problems creatively, and make sound decisions in a fast-paced environment
• Strong organizational skills with the ability to manage competing priorities and conflicting deadlines while maintaining attention to detail
• Confidence to challenge assumptions, ask insightful questions, and exercise sound judgement when navigating regulatory uncertainty
• Resilience, initiative, and strength of character to take ownership of work, influence stakeholders, and see tasks through to completion
• Curious, collaborative, and motivated by making a meaningful impact through innovative medical technologist
• Degree in Engineering, Biomedical Engineering, Industrial Design, Science, or similar
• 4+ years in medical device development or manufacturing
• 3+ years in Regulatory Affairs within medtech
• Experience preparing regulatory submissions and supporting approvals
• Strong understanding of ISO 13485, EU MDR, 21 CFR 820
• Experience with FMEA, Hazard Analysis, and risk management
• ISO 13485 Auditor / Lead Auditor (desirarable)
• RAC, FRA, or equivalent credential (desirable)

Why Join IDE?

• Purpose driven work that improves lives
• Diverse projects across the full product life cycle
• Global exposure in Australia, USA, Netherlands
• Multidisciplinary collaboration across design, engineering, and commercialization
• Mentoring and professional development
• Employee benefits including an EAP

If this sounds like you, we’d genuinely love to hear from you.

Requirements:

• Bachelor’s Degree
• Degree 2+ years of work experience with Medical Devices