Julia Korus - Independent Consultant

Unterägeri, Tanzania, United Republic of

Experience

Mar 2025 - Present

11 months

May 2012 - Feb 2025

12 years 10 months

Supporting IVD and medical device companies in setting up quality management systems for medical devices and IVD (MDR/IVDR, ISO 13485, MDSAP FDA 21 CFR 820) and improving processes
Technical documentation according to MDR/IVDR
Risk management according to ISO 14971:2019 and ISO 24971
Usability engineering according to IEC 62366-1/2
Project management in development projects
Software lifecycle management
Labeling & UDI
Global product registration strategies, international submissions (STED files, 510(k)s, Health Canada submission)
Complaint handling & CAPA management, vigilance and post-market surveillance
MDSAP auditor
Providing training & coaching

Apr 2011 - Apr 2012

1 year 1 month

Oct 2010 - Mar 2011

6 months

Jan 2009 - Sep 2010

1 year 9 months

Coordination of worldwide registration of medical devices (Class I to III)
Review, creation and maintenance of technical documentation and submission dossiers
Providing regulatory strategy
Process improvement
Review labeling (labels, user manuals and promotional material)
Communication with registration & certification bodies
Risk management & usability engineering
Research and management of applicable standards
Training and coaching of the project team

Mar 2008 - Dec 2008

10 months

Switzerland

Oct 2000 - Feb 2008

7 years 5 months

Switzerland

(Sub-)project management of new accessories and components for surgical microscopes (digital, video system, DICOM interface, foot control panel and hand switch, fluorescence accessories, GUI software, integrated display, interface for image-guided surgery systems)
System integration
Coordination and support of product certification and EMC testing
Technical documentation
Writing user, installation and service manuals
Service and marketing training

Apr 1998 - Aug 2000

2 years 5 months

Ce Marking Of Ivds And Medical Devices (Class I-iii)
Medical Device Registration In Japan (Pal) And China (Sfda)
Medical Device Regulation In Asia Pacific
Medical Device Registration In Canada (Cmdcas) And The Us (Fda 21 Cfr 820, 510(k))
Iec 60601-1 2nd And 3rd Edition
Usability Of Medical Devices According To Iec 60601-1-6 And Iso 62366
Medical Device Software Iec 62304
Risk Management Iso 14971
Quality Management Iso 13485
Project Management
Requirements Engineering
Itil V2 / Foundation Certificate In It Service Management (Exin)
Further Education (Internal) In Optics, Microscopy, Ophthalmology And Neurosurgery
Mdr & Ivdr
Mdsa Lead Auditor
Iec 82304
Very Good Knowledge Of Microsoft Office (Excel, Word, Powerpoint, Visio)
Mindjet Mindmanager
Scio Fmea
Qware Risk Manager
Polarion
Veeva Vault
Sap
Several Programming Languages Such As Xml, Html, Sql, Assembly, Modula 2, C++, Basic
Ability To Organize, Structure And Plan Strategically
Target- And Goal-oriented Work
Analytical Thinking
Willingness To Perform
Enthusiasm
Ability To Work Under Pressure
High Social Skills
Good Team Player
International Experience
Willingness To Travel