Regulatory Affairs Specialist II – Lingo (on-site)
Core
Prepare regulatory submissions and documentation for medical device product market entry, ensuring compliance with FDA and international regulations.
Role type
Specialist-level Regulatory Affairs Specialist
Builds
Regulatory submissions for biosensing medical devices
Domain
Healthcare / Medical Devices / Biosensing
Required skills
Regulatory submission preparation, Engineering change order review, Regulatory guideline analysis, International regulation maintenance, Product release support, Advertising material review
Preferred skills
Science degree (biology, chemistry, engineering), Master's in Regulatory Affairs, Capital equipment regulatory experience, RAC certification
Technologies
FDA regulatory systems, International regulatory databases
Responsibilities
Prepare regulatory submissions for devices, Review and approve engineering change orders, Maintain domestic and international medical device regulations, Support product release process, Collaborate on advertising and promotional material reviews, Comply with FDA and international regulations
Seniority
Mid-level, hands-on IC