Tanja Rohark

Basic

Digitalisation Life Science & Healthcare/ Lean & Agile QMS-Regulatory Compliance

Inhaberin, CEO & Founder, Digital Chameleon GmbH

Bis 2021, MSc. Information Technologies in Healthcare, Universität Krems

Basel, Switzerland

About me

Digital Transformation in Life Science & Health Care Are you also facing the regulatory challenges of digitalization in the life science and healthcare sectors? Do you feel the limits of traditional approaches in quality & compliance management? Or are you looking for a supportive and enthusiastic team of experts to master the development of digital healthcare solutions? Such as software as a medical device, health apps and digital health platforms. We help the regulated industry with out-of-the-box approaches to agile, lean and effective quality management and regulatory compliance with our Quality Revolution Methodology. Let us navigate you through the regulatory jungle. We understand your challenges. Meet me for a virtual coffee. I look forward to our exchange. https://calendly.com/tanja-rohark/vc

Skills

Digital Health
Qualitätsmanagement
Software as a Medical Device
IT Project Management
quality and compliance in the regulated industry
IT Quality Assurance
Business Analysis
Prozess Management
Change-Management
Quality Management
BPM
Business Process Management
Business Analyst
IT Audit
Prozessmodellierung
Prozessoptimierung
Transition Management
Transformation and Organizational Change
Change Kommunikation
Organisationsentwicklung
Systemische Beratung
Supply Chain Management
SOP
Data Management
Data Migration
Design Thinking
Scrum
Public Relations
Coaching
Business Process Excellence
Computer System Validation
CSV
GxP
IDMP ISO Identification of Medicinal Products
RIM Regulatory Information Management
Electronic Document Management Systems (EDMS)
Audit and Assessment
Strategy and Advice
Business Excellence and Continuous Improvement
SAP ERP
MES
Master Data Management (SAP MDM)
GMP Compliance
Pharmaindustrie
Systemvalidierung nach GAMP
Document Lifecycle Management
System Testing
Risikomanagement
FMEA
System Development Life Cycle
Agile Softwareentwicklung
HP Quality Center
Document Management Solutions
SAP Softwareentwicklung
ARIS-Prozessmodellierung
ECM Documentum
Requirements Engineering
Business Engineering
Digital Healthcare
E-Health
Medical Devices
ISO 13485
ISO 14971 Riskikomanagement Medical Devices
IEC 62304
Medizinische Software
Medizinprodukte
Medizinprodukterichtlinie (MDD 93/42/EC)
Medizingerätesoftware
Medical Device Software
Usability Engineering
ISO 14971 Risk Management
ISO 27001
CAQ-Software
Majesty Software
Bewertung und Management-Auditing
Auditing
Software Quality Assurance
Digitalisierung
Business-Analyse
Quality assurance
13485
Platform
Qualitätsmanagementsystem
Usability
MDR
Audit
Projektmanagement
Softwareentwicklung
ISO 134852003
GDPR
ISMS
Informationssicherheit
Datenschutz
Medizintechnik
Medizinprodukt
Qualitätsmanagement im Gesundheitswesen
Zulassungsmanagement
FDA
Cybersecurity
Künstliche Intelligenz

Timeline

Professional experience for Tanja Rohark

  • Current 3 months, since Nov 2021

    Co-founder

    Digital Salon Basel

  • Current 2 years and 11 months, since Mar 2019

    CEO & Founder

    Digital Chameleon GmbH

    Quality Revolution with Swiss Excellence As Digital Chameleon, we are helping to create a better world of effective healthcare by driving change for a connected Digital Health Ecosystem We reinvent and transform quality for the digital evolution by navigating our customers through the complex regulatory environment (ISO, FDA, EMA, MDR) in a resilient and secure way.

  • Current 10 years and 1 month, since Jan 2012

    Digital Health Technology Specialist (Freelance)

    Rohark Consulting

    Quality Management and Assurance for Software Development of Medical Device Software and Computerized Systems, Regulatory Compliance within Pharmaceuticals and Medical Device industry (EMA, FDA, PIC/S, ISO, MDD), Quality Risk Management (FMEA, ISO 14971), Software Validation and Verification (IEC 623304/82304, GAMP 5/ CSV), Business Analysis/ Requirements and Usability Engineering (BABOK, IREB, IEC 62366), Digital and Mobile Solutions Development, Digital Health, Agile/Scrum, Design Thinking

  • 8 months, May 2014 - Dec 2014

    Consultant Transformation Management

    Novartis Pharma AG

    Transition of Master Data Management and Operational Sourcing from Basel/Switzerland to Hydera-bad/India in PharmaSupply Organization • Business Process Analysis and Optimization, Gap Analysis • Development of value-creation and harmonized processes within all involved functions: Quality, Supply Chain, Sourcing and Finance • Improvement of Standard Organization Procedures (SOP) including process flows • Change Management, Change Communication • Training Development, Training Coordination

  • 7 months, Oct 2013 - Apr 2014

    Project Quality Manager and Analyst (PQM)

    Novartis Pharma AG

    Project Quality Management and Analysis, Oracle Agile, SAP SCM, CSV Computer System Validation

  • 6 months, May 2013 - Oct 2013

    SAP Data Migration Manager

    Novartis Pharma AG

    Supply Chain Management, SAP SCM, SAP Data Migration Management: object identification, mapping, cleansing, conversion, testing, migration, and cutover of approved master and transactional data object

  • 5 months, Dec 2012 - Apr 2013

    Consultant Supply Data Management

    Novartis Pharma AG
  • 3 months, Sep 2012 - Nov 2012

    Consultant Process & Change Management

    Novartis AG, Basel

    BPM Business Process Management, Business Analysis, Change Management, Change Communikation, Projektmanagement, SAP Migration Management, Master Data Management, Supply Chain Management, Trainings, SAP SCM, Training

  • 6 months, Feb 2012 - Jul 2012

    Assistant to Vice President Business Transformation & T-Gallery

    Deutsche Telekom AG, Products & Innovations

    Projektmanagement, PMO, Innovationsmarketing, Transformation, Change Management, PMI Program Management, T-Gallery, Design Thinking, Scrum

  • 2 years and 2 months, Nov 2009 - Dec 2011

    Freie Journalistin & Beraterin für PR/ Presse- und Öffentlichkeitsarbeit

    Fast Fortune - Agentur für Corporate Relations

    Agentur für Corporate Relations: Mensch-zu-Mensch Kommunikation für werteorientierte Unternehmen, kreative und ausgewogene PR-Konzepte & Kampagnen, Public Relations, Online & Media Relations, Communication Design

  • 1 year and 1 month, May 2010 - May 2011

    Redaktionsleitung, Freier TV-Redakteur

    SEEMA Media

    RTL Punkt 12, RTL exklusiv, VOX prominent: TV-Produktion, TV-Reportagen, Magazinbeiträge, Boulevard, Redaktionsleitung, Themenrecherche, Treatments, Texten von Beiträgen, Produktion

  • 1 year and 3 months, Sep 2008 - Nov 2009

    Public Relations & Social Media Manager

    zeitlos; elektronisch

    Kulturmanagement, Künstlermanagement, Musikpromotion, Bookings & Promotion, Kommunikation für die Kultur- und Kreativwirtschaft, Musikwirtschaft und Popkultur, Blog für elektronische Musik und Popkultur

  • 1 year and 6 months, Jun 2008 - Nov 2009

    Public Relations & Social Media Manager

    Sternschaltung - Agentur für Kulturmanagement, PR und Kreativberatung

    Juicy Beats Festival, Audiodigitale Festival für Medienkunst, Artist Marsen Jules: Text und Konzeption Website, Programmheft, Werbemittel, Newsletter, Content und Layout myspace (HTML), Presse-/Medienarbeit, Sponsoring, Bookings, Künstlerbetreuung, Koordination Convention, Newsletter, Online PR auf facebook, myspace, twitter, last.fm, flickr etc.

  • 1 year and 1 month, Sep 2008 - Sep 2009

    Public Relations & Social Media Manager

    kommheim - Kreatives Eventment

    VRSTCK Club & VRSTCK Blog, Dortmund: Text und Konzeption Imagekampagne, Website, Newsletter, PR/Öffentlichkeitsarbeit, Pressarbeit, Content Management, Konzeption und Redaktion Blog, Online PR auf facebook, myspace, twitter, last.fm, flickr etc., Musikprogramm, Bookings & Promotion

  • 2008 - 2008

    Assistenz der Geschäftsführung

    virtual:nights:media Ltd.

    Schwerpunkte: Web 2.0, Social Communities, Onlinemarketing, Online Redaktion, Text und PR/Öffentlichkeitsarbeit, Content Management, Konzeption Werbekampagnen, Eventmanagement: Text und Konzeption Unternehmenspräsentation und Werbemittel, Content Management und Layout Mediawebsite (MODx), Online Redaktion

  • 2006 - 2008

    Assistenz der Geschäftsführung

    Deloitte

    Schwerpunkte: Assistenz des Geschäftsführers, Kundenmanagement, Text und PR/Öffentlichkeitsarbeit, Content Management, Messeplanung- und koordination: Content Management und Layout Unternehmenswebsite (Vignette), Text und Konzeption, Unternehmensbroschüren und Produktflyer, Pressemappe

  • 2005 - 2006

    Assistenz des Abteilungsleiters

    RWE Power AG

    Schwerpunkte: Assistenz des Abteilungsleiters, Koordination des Abteilungs- und Direktionsbüros, Verfassen von Präsentationen und Vorträge

  • 2003 - 2005

    Kontakterin, Event- und Projektmanagement

    Stein All in All Marketing GmbH

    Schwerpunkte: Projektmanagement Sponsorings, Events und Product Placement in TV- und Kinoproduktionen, Text und Konzeption, PR/Öffentlichkeitsarbeit

Educational background for Tanja Rohark

  • 1 year and 10 months, Sep 2019 - Jun 2021

    MSc. Information Technologies in Healthcare

    Universität Krems

  • 7 months, Jun 2019 - Dec 2019

    ISO 27001 Information Security Officer and Lead Auditor

    TÜV SÜD Gruppe

  • 1 month, May 2019 - May 2019

    IT & Cybersecurity and Data Privacy for Medical Devices

    Johner Institute

  • 1 month, Oct 2018 - Oct 2018

    Software Engineering

    Johner Institut

    Teacher: Thomas Geis, editor of ISO 9241-100, -110, -112 /IEC 25060 (CIF): Usability engineering, specification and user interfaces design, verification and validation of usability respectively formative and summative usability evaluation, Interaction of development, risk management, Usability file

  • 1 month, Jun 2018 - Jun 2018

    Medical Device Software Development

    Johner Insitut

    •IEC 62304 and FDA •SOUP and legacy software •Risk Management according to ISO 14971 •Quality management

  • 3 years and 1 month, Dec 2017 - Dec 2020

    BSc. Klinische Psychologie, Gesundheits- und Rehabilitationspsychologie

    SRH Fernhochschule Riedlingen

  • 1 month, Nov 2013 - Nov 2013

    Quality Assurance Engineering

    Novartis

    CSV/ Project Quality Manager based on PMI: Novartis ICE IQP Crystal Excellence, Six Sigma, Lean Manufacturing

  • 3 months, Apr 2013 - Jun 2013

    Beratung und Coaching

    Hochschule Wismar, University of Technology, Business and Design

    St. Galler Management Modell, Themenzentrierter Interaktionsansatz, Systemische Organisationberatung, Systemische Fragetechniken

  • 7 months, Nov 2012 - May 2013

    Alwart Institut Hamburg

  • 8 months, Feb 2009 - Sep 2009

    Deutsches Institut für Publizistik

Languages

  • German

    First language

  • English

    Fluent

Wants

Projektmanagement
Change Management
Business Transformation
Business Consulting
Quality Management
IT Project Management
IT Quality Assurance
Computer System Validation
E-Health
Digital Health
Medical Devices
eHealth
Freelancing
IT-Projektmanagement
Freiberufliche Mitarbeit
Medizintechnik
IT-Audits
Quality assurance
IT-Consulting
Software as a Medical Device

Interests

Digital Health

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