Arhamis Lazaro Medina
Technical Specialist and Scheme Manager @BSI
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WORK HISTORY
Technical Specialist and Scheme Manager @BSI
Austin, TX, US
Conducted detailed technical assessments of medical devices to determine compliance with EU MDR and MDD, focusing on general medical devices.Managed full certification lifecycle as Scheme Manager for multiple manufacturers across Europe and globally.Delivered audits under ISO 13485, ISO 9001, MDSAP, and MDR as Lead Auditor across a wide range of device types.Provided expert regulatory input on clinical evaluation, risk management, and post-market surveillance during conformity assessments.Played a key role in the MDR transition strategy for clients, supporting remediation plans and technical documentation readiness.Collaborated with internal teams to ensure compliance with Notified Body procedures and EU designation requirements.
EDUCATION
Universidad de Sevilla
Technical Engineer in Product Design, Escuela Universitaria Polictecnica de Sevilla
Politecnico di Torino
Tesi finale
SKILLS
ABOUT ARHAMIS LAZARO MEDINA
Experienced Regulatory Affairs and Quality Assurance professional with 8+ years at a leading Notified Body (BSI Group), working as Scheme Manager, Technical Specialist, and Lead Auditor across general medical devices.I specialize in EU MDR, MDSAP, ISO 13485, ISO 9001, and technical documentation review for CE Marking. I’ve led global audits and certification projects, collaborated with manufacturers during regulatory transitions, and delivered assessments that align with best practices and regulatory expectations. Specialties: ISO 13485:2016, Medical Device Regulation (2017/745), Medical Device Directive (93/42/EEC), Medical Device Single Audit Program (MDSAP) covering quality system requirements for medical devices in Australia, Brazil, Canada, Japan and the USA.Regulatory Affairs | Quality Assurance | EU MDR | MDSAP | ISO 13485 | CE Marking | Medical Devices | Lead Auditor | Technical Documentation | PMS | QMS
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