Skip to main content
Tallo logoTallo logo
Apply for this opportunity

This job application is on an outside website. Be sure to review the job posting there to verify it's the same.

Apply Offsite

Regulatory Affairs Specialist

Job

IDE Group

Philadelphia, PA (In Person)

Full-Time

Posted 4 weeks ago (Updated 17 hours ago) • Actively hiring

Expires 8/6/2026

Review key factors to help you decide if the role fits your goals.
How is this calculated?
Pay Growth
?
out of 5
Not enough data
Not enough info to score pay or growth
Job Security
?
out of 5
Not enough data
Calculating job security score...
Total Score
73
out of 100
Average of individual scores

Were these scores useful?

Skill Insights

Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.

Job Description

Location:
Philadelphia,USA Salary:
Published On:
June 9, 2026 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 (desirarable) 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.