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Michelle R.MR

Michelle R.

Regulatory Affairs Specialist for Medical Devices

1.250 €/Tag
Kyrenia, CY
15+ Jahre

Durchschnittliche Reaktionszeit: 1h

Über Michelle

Helping clients in regulated industries (with a particular focus on Medical Devices and Life Sciences) to ideate, define, challenge and implement strategies, business models, target operating models, technologies and implementation roadmaps in order to master the challenges of complex Programs & Projects, Quality Assurance & Regulatory Affairs, Digital Transformation, the Internet of Things, Industry 4.0 topics, and relevant underlying, related and cross-cutting themes and technologies, such as Robotics, Factory Automation, Machine Learning, and Cloud Computing.

Facilitating and leveraging methodologies and strategies such as Design Thinking, Innovation & Knowledge Management, Human-Centered Design, Customer Journey etc, to create awareness and build up momentum for implementing a truly Digital Culture throughout the entire organization, as an indispensable precondition of successful Digital Transformation.

Demonstrating leadership by example in roles such as Program & Project Management, Quality / Regulatory Affairs / GRC Management, Transformation Management, and Requirements Management.
  • Englisch

    Muttersprachlich oder zweisprachig

  • Deutsch

    Muttersprachlich oder zweisprachig

  • Spanisch

    Grundkenntnisse

Nur remote
Führt Projekte hauptsächlich remote aus

Projekt- und Berufserfahrung

  • Various
    QA/RA, GRC, CS Consultant
    MEDIZIN
    Januar 2021 - Heute (5 Jahre und 7 Monate)
    remote for international clients
    GRC (Governance/Risk/Compliance), QA/RA (Quality Assurance / Regulatory Affairs), CS (Cyber Security) – Submission of documents for registration of Medical Devices & Regulatory Requirements / Best Practice
  • Various
    Digital Transformation Advisor
    INTERNET DER DINGE
    November 2018 - Februar 2021 (2 Jahre und 4 Monate)
    remote for international clients
    Digital Transformation – Digital Culture, New Work, Enterprise 4.0, Customer & User Experience, IoT, Robotics, Industry 4.0, Factory Automation, Big Data, Cloud, Cyber Security
  • Belimed
    Global Program Manager ― Digital Transformation & Solutions
    MEDIZIN
    Mai 2016 - Oktober 2018 (2 Jahre und 6 Monate)
    Zug, Schweiz
    Global lead of the "Connectivity Solutions" program, the company’s effort to bundle all ideas, resources, assets, R&D activities, and client solutions relating to the company’s digital transformation under a joint oversight and governance body responsible for coordinated planning, management, and project execution, in order to maximize efficiency and synergies, and to minimize overhead and duplicate work.

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Zertifizierungen

  • IPMA Certified Project Manager
    IPMA

Fähigkeiten

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