Senior Regulatory Affairs Specialist

More Results Senior Regulatory Affairs Specialist Employer IDE Group Location Philadelphia, Pennsylvania, US Salary Competitive Closing date Jul 10, 2026 View more categories View less categories Sector Consultancy/Private Sector Field Conservation science Discipline Biology Job Level Senior level Salary Type Salary Employment Type Full time Apply on website Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Job Description 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 strat egy across medical device development projects Prepare global submissi ons for Australia, USA, and Europe Ensure compliance with

ISO 13485, EU

MDR, and 21 CFR 820 Develop technical documentat ion and quality records Facilitate risk management including FMEA and Hazard Analysis Assist with regulatory and quality requirements Improve IDE's Quality Management sys tem 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 Aff airs within medtech Experience preparing regulatory submissions and supporting approvals Strong understanding of

ISO 13485, EU MDR, 21 CFR 820

Experience w ith FMEA, Hazard Anal ysis, 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 Share this job Facebook Twitter LinkedIn Apply on website Send job Apply on website Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert