Miriam A. Rosario headshot

Miriam A. Rosario

Associate Director of Regulatory Affairs

Miriam is a trained quality systems professional with extensive experience in FDA and ISO quality systems requirements and an extensive background in cGMP environments for medical devices, biologics, finished pharmaceuticals, in vitro diagnostics, dietary supplements, API and combination products.

Over the course of her career, Miriam has managed and audited multiple plants for numerous companies in the US, South America, Europe, and Asia, and has served as a worldwide independent consultant. She is a subject matter expert for industry regulations including QSR, 21 CFR Parts 11, 111,211, 820, ISO 9000/13485/14971 and the Medical Device Directive and can readily advise clients on supplier qualification and management, production and process controls, equipment qualification, CAPA, investigations, recalls, MDRs, establishment registration/licensing, and product listings.

Multilingual, Miriam graduated with a BS in chemistry from the Universidad de Puerto Rico, Bayamon & Manati.

 

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