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Senior Regulatory Affairs Specialist - Medical Devices (Hybrid)

6AM City, LLC

6AM City, LLC is seeking a Sr. RA Specialist for a hybrid role based in Pennsylvania. The position supports FDA submissions (510(k)/NTF) for US, Canada, and EU, and maintains regulatory databases and labeling for medical devices. Requires a Bachelor's degree and 4–6 years in Regulatory Affairs with experience supporting regulatory teams. Key duties include compiling submissions, interfacing with Product Development, updating change controls, and advising on regulatory strategy to ensure #J-18808-Ljbffr 6AM City, LLC

Vacancy posted 1 day ago
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