Diana Gavrilov Negev
Quality Assurance Specialist & Clinical Affairs Manager @Hanita Lenses Ltd
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WORK HISTORY
Quality Assurance Specialist & Clinical Affairs Manager @Hanita Lenses Ltd
I serve as a freelance Quality Assurance and Clinical Affairs Manager for Hanita Lenses, supporting regulatory compliance, clinical documentation, and quality system excellence for ophthalmic medical devices, including intraocular lenses (IOLs).Quality Assurance ResponsibilitiesLead the maintenance and continuous improvement of the ISO 13485:2016-compliant QMS in alignment with EU MDR 2017/745 and FDA 21 CFR Part 820.Manage internal audits, CAPA investigations, and nonconformance reports (NCRs), ensuring timely resolution and systemic corrective action.Oversee risk management activities per ISO 14971, including review and approval of design files and process validations.Support sterilization validation, labelling control, and design transfer for new and existing IOLs.Prepare for and support Notified Body audits, regulatory inspections, and management reviews.Define and track quality KPIs, ensuring transparency, control, and ongoing compliance.Clinical Affairs ResponsibilitiesDevelop and maintain Clinical Evaluation Reports (CERs) in accordance with MEDDEV 2.7/1 Rev. 4 EU MDR Annex XIV.Design and implement Post-Market Clinical Follow-up (PMCF) plans and reports to support safety and performance claims.Conduct in-depth literature reviews, risk-benefit analyses, and integration of clinical data into regulatory submissions.Collaborate with R&D, regulatory, and medical teams to ensure clinical evidence supports product claims and meets global requirements.Respond to Notified Body queries regarding clinical documentation and strategy.I bring a hands-on, cross-functional approach to freelance consulting—merging quality, clinical, and regulatory insight to help Hanita Lenses deliver safe, effective, and globally compliant ophthalmic products. My focus is on building robust systems, enabling market access, and supporting product excellence from concept to commercialization.
EDUCATION
GCP academy
Diploma, CRA - clinical research associate
British Columbia Institute of Technology
Associate's degree, Business Administration and Management, General
The Hebrew University of Jerusalem
Bachelor's degree, Biology/Biological Sciences, General
Ono Academic College
Master of Business Administration - MBA, Management of health and pharmaceutical systems
ABOUT DIANA GAVRILOV NEGEV
I’m a Clinical Affairs Manager and Quality Assurance Professional with over 8 years of…
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