Julia Korus - Independent Consultant

Q: Where is Julia based?

Julia is based in Unterägeri, Tanzania, United Republic of and prefers 100% remote projects.

Q: What languages does Julia speak?

Julia speaks the following languages: German (Native), English (Advanced), French (Elementary) .

Q: How many years of experience does Julia have?

Julia has at least 28 years of experience. During this time, Julia has worked in at least 8 different roles and for 7 different companies . The average length of individual experience is 4 years and 6 months . Note that Julia may not have shared all experience and actually has more experience.

Q: What is Julia's latest experience?

Julia's most recent position is Independent Consultant at Independent Consultant .

Q: What companies has Julia worked for in recent years?

In recent years, Julia has worked for Independent Consultant and JKorus GmbH .

Q: Which industries is Julia most experienced in?

Julia is most experienced in industries like Healthcare and Manufacturing .

Q: Which business areas is Julia most experienced in?

Julia is most experienced in business areas like Quality Assurance , Project Management , and Product Development . Julia also has some experience in Operations and Legal .

Q: Which industries has Julia worked in recently?

Julia has recently worked in industries like Healthcare .

Q: Which business areas has Julia worked in recently?

Julia has recently worked in business areas like Project Management and Quality Assurance .

Recommended expert

Unterägeri, Tanzania, United Republic of

Check rate

Experience

Mar 2025 - Present

1 year 5 months

Independent Consultant

May 2012 - Feb 2025

12 years 10 months

Regulatory Affairs Services

JKorus GmbH

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

Head of Regulatory Affairs

Medela AG

Team leading
Worldwide registration of medical devices (class I to IIb)
Creation and maintenance of technical documentation and submission dossiers
Coordination of safety testing
Usability engineering
Design & development process
Software lifecycle management
Document management
Clinical evaluation
Sterile products
Labeling
Training & coaching
Research and management of applicable standards

Oct 2010 - Mar 2011

6 months

Regulatory Affairs Leader EMEA

GE Healthcare IT

EMEA registration of medical software (class I to IIb)
Risk management
Software lifecycle management
Usability engineering
Technical documentation
Labeling
Research and management of applicable standards
Training and coaching

Jan 2009 - Sep 2010

1 year 9 months

Regulatory Affairs Manager

Carl Zeiss Surgical GmbH

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

Regulatory Affairs Coordinator

Leica Microsystems (Switzerland) AG

Worldwide registration of class I and II medical devices and IVD
Review, creation and maintenance of technical documentation
Coordination of product certification according IEC 60601-1 and EMC testing
Risk management
Training
Introduction of the standard database "Globalnorm"

Oct 2000 - Feb 2008

7 years 5 months

Switzerland

R&D Engineer and Project Manager

Leica Microsystems (Switzerland) AG

(Sub-) Project management of new accessories & 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 & marketing training

Apr 1998 - Aug 2000

2 years 5 months

Management, Surgery Nurse, Doctor’s Assistant

Medical Practise Dr. Thomas Mack / Ambulatory Surgery Center Römerpark

Management
Surgery nurse
Doctor’s assistant (including X-ray, casting, wound management)

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Healthcare and Manufacturing.

Healthcare

Manufacturing

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Project Management, Product Development, Operations, and Legal.

Quality Assurance

Project Management

Product Development

Operations

Legal

Skills

Ce- Marking Of Ivds And Md 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/3rd Edition
Usability Of Medical Devices According To Iec 60601-1-6 And Iso 62366
Medical Device Software Iec 62304
Risk Management Iso 14971
Qm 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, Assembler, Modula 2, C++, Basic
Ability To Organize, Structure And Plan Strategically
Target- And Goal-Oriented Working
Analytical Thinking
Willingness To Perform
Enthusiasm
Ability To Work Under Pressure
High Social Skills
Good Team Player
International Experience
Willingness To Travel

Languages

German

Native

English

Advanced

French

Elementary

Education

Mar 2011 - Dec 2011

Institut für IT im Gesundheitswesen, Danube University Krems

MBA, Health Information Management · Health Information Management · Konstanz, Germany

Sep 2007 - Jun 2009

Institut für IT im Gesundheitswesen, Danube University Krems

Master of Science, Health Information Technologies · Health Information Technologies · Freiburg im Breisgau, Germany

Oct 1992 - Jun 1998

University of Hildesheim

Medical Informatics · Hildesheim, Germany

...and 1 more

Certifications & licenses

Regulatory Backgrounds and Trend Reporting

MDR Online Conference on «SaMD»

JKorus GmbH

Post-Market Surveillance

DtN EN ISO T34BS and MDR/IVDR

Mini-Course MDR 2017/745

Market Access and Basics of Regulatory Affairs for Start-Ups in Medical Technology

ISO 13485:2016 Certification Training

Medical Device Academy, Inc.

Sufficient Clinical Evidence under MDR (EU) 2017/745

RISK MANAGEMENT REVISITED

RAPS

MDR/IVDR - Status Report from Stakeholders

CQI/IRCA Certified Quality Management Systems Lead Auditor Training

NSF Health Sciences, Medical Devices

University Certificate Regulatory Affairs for Medical Technology Part 1

University Certificate Regulatory Affairs for Medical Technology, Part 3

University Certificate Regulatory Affairs for Medical Technology, Part 2

Amendments of IEC 82304.1

PROSYSTEM AG

ITIL V2/ Foundation Certificate in IT Service Management

EXIN

Statistics

Experience

Total positions 8

Experience in Healthcare 26.5 y

Avg length 3 y 5 m

Longest experience 12 y 9 m

Global Experience

Countries worked in 1 (Switzerland)

Primary country Switzerland

Expertise

Recent roles Independent Consultant, Regulatory Affairs Services, Head of Regulatory Affairs

Main industries Healthcare, Manufacturing

Main business areas Quality Assurance, Project Management, Product Development

Qualifications

Highest degree Master

Certifications earned 16

Profile

Created

January 2026

Last Update

April 2026

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Frequently asked questions

Have questions? Find more information here.

Where is Julia based?

Julia is based in Unterägeri, Tanzania, United Republic of and prefers 100% remote projects.

What languages does Julia speak?

Julia speaks the following languages: German (Native), English (Advanced), French (Elementary).

How many years of experience does Julia have?

Julia has at least 28 years of experience. During this time, Julia has worked in at least 8 different roles and for 7 different companies. The average length of individual experience is 4 years and 6 months. Note that Julia may not have shared all experience and actually has more experience.

What roles would Julia be best suited for?

Based on recent experience, Julia would be well-suited for roles such as: Independent Consultant, Regulatory Affairs Services, Head of Regulatory Affairs.

What is Julia's latest experience?

Julia's most recent position is Independent Consultant at Independent Consultant.

What companies has Julia worked for in recent years?

In recent years, Julia has worked for Independent Consultant and JKorus GmbH.

Which industries is Julia most experienced in?

Julia is most experienced in industries like Healthcare and Manufacturing.

Which business areas is Julia most experienced in?

Julia is most experienced in business areas like Quality Assurance, Project Management, and Product Development. Julia also has some experience in Operations and Legal.

Which industries has Julia worked in recently?

Julia has recently worked in industries like Healthcare.

Which business areas has Julia worked in recently?

Julia has recently worked in business areas like Project Management and Quality Assurance.

What is Julia's education?

Julia holds a Master in Health Information Management from Institut für IT im Gesundheitswesen, Danube University Krems and a Master in Health Information Technologies from Institut für IT im Gesundheitswesen, Danube University Krems.

Does Julia have any certificates?

Julia has 16 certificates. Among them, these include: Regulatory Backgrounds and Trend Reporting, MDR Online Conference on «SaMD», and Post-Market Surveillance.

What is the availability of Julia?

Julia is immediately available full-time for suitable projects.

What is the rate of Julia?

Julia's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.