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bengreen927

Ben G

@bengreen927

FDA regulatory writer and ISO 13485 QMS specialist for medical devices

Estados Unidos
Inglês, Português
Algumas informações são exibidas no idioma inglês.
Sobre mim
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.... Saiba mais

Habilidades

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bengreen927
Ben G
offline • 

Conheça meus serviços

Regulamentação de dispositivos médicos
I will design your fda clinical study protocol and endpoint strategy
A partir deUS$ 600 /projetoMais detalhes
Regulamentação de dispositivos médicos
I will write sops and quality documents for your medical device company
A partir deUS$ 600 /projetoMais detalhes

Experiência profissional

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.