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bengreen927

Ben G

@bengreen927

FDA regulatory writer and ISO 13485 QMS specialist for medical devices

États-Unis
Anglais, Portugais
Certaines informations sont présentées en anglais.
À propos de moi
Medical device regulatory and quality systems specialist with hands-on experience across ISO 13485, 21 CFR 820/QMSR, EU MDR, and FDA submissions. I write SOPs, quality manuals, risk management files (ISO 14971), DHFs, and regulatory submission packages — delivered on time and audit-ready. My background spans startups to established device companies, covering design controls, CAPA, process validation, supplier management, and post-market surveillance. BSI ISO 13485 certified. Fluent in English and Portuguese.... Plus d’infos

Compétences

b
bengreen927
Ben G
hors ligne • 

Voir mes services

Réglementation des dispositifs médicaux
I will design your fda clinical study protocol and endpoint strategy
De600 $US / projetPlus de détails
Réglementation des dispositifs médicaux
I will write sops and quality documents for your medical device company
De600 $US / projetPlus de détails

Expérience professionnelle

Quality and Regulatory Affairs Manager

Medical Device Startup

Jan 2021 - Present • 5 yrs 4 mos

Lead quality management system implementation and regulatory affairs for Class II medical devices. Key responsibilities and deliverables include: ISO 13485 QMS design, implementation, and maintenance; FDA 510(k) premarket submissions and regulatory strategy; Design History File (DHF) creation including design controls, V&V protocols, and risk management per ISO 14971; Standard Operating Procedures (SOPs) for manufacturing, CAPA, document control, and supplier management; EU MDR technical documentation and CE marking support; Internal audit programs and CAPA management; Process validation protocols (IQ/OQ/PQ); Quality manuals, work instructions, and training documentation.