Regulatory Affairs Specialist
IDE GROUP LLC
Senior Regulatory Affairs Specialist
Location: Philadelphia, USA
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.
About the role
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
About you
What You Bring
- Degree in Engineering, Biomedical Engineering, Industrial Design, Science, or similar
- 4+ years in medical device development or manufacturing
- 2+ 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 (desirable)
- RAC, FRA, or equivalent credential (desirable)
- Curious, collaborative, and motivated by meaningful impact
Why 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 commercialisation
- Mentoring and professional development
- Employee benefits including an EAP
If this sounds like you, we'd genuinely love to hear from you.
Ready to join the team?
If you are ready to be challenged but fulfilled, and have the right skills, experience and, most importantly, the right attitude, then a truly unique role in a life-changing product development company awaits.
Apply now
Vacancy posted 4 days ago
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