About this role
Regulatory Engineer at Cryoport. Location: Ball Ground, Georgia, United States. Role: supporting design, managing risk, maintaining documentation Requirements: Bachelor's in Engineering required; experience in regulated industries (medical devices preferred); working knowledge of FDA, ISO 13485, EU MDR/MDD, design controls, risk management, change control; strong technical writing and cross-functional collaboration skills. Category: Quality Assurance Seniority: Mid Level Tools: ISO 13485, ISO 14971, EU MDR/MDD, FDA, FMEA, DHF, DMR, CAPA Commitment: Full Time Workplace: Onsite Languages: English