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Nederlands
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Ben G
@bengreen927
FDA regulatory writer and ISO 13485 QMS specialist for medical devices
Verenigde Staten
Engels, Portugees
Over mij
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.
Skills
Ben G
offline •
Bekijk mijn diensten
Regelgeving voor medische hulpmiddelen
I will design your fda clinical study protocol and endpoint strategy
Regelgeving voor medische hulpmiddelen
I will write sops and quality documents for your medical device company
Werkervaring
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.
