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Michelle R.MR

Michelle R.

Regulatory Affairs Specialist for Medical Devices

€1,250/day
Kyrenia, CY
15+ years

Average response time: 1 hour

About 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.
  • English

    Native or bilingual

  • German

    Native or bilingual

  • Spanish

    Basic

Remote only
Primarily works remotely

Experience

  • Various
    QA/RA, GRC, CS Consultant
    MEDICAL
    January 2021 - Today (5 years and 7 months)
    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 OF THINGS (IOT)
    November 2018 - February 2021 (2 years and 4 months)
    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
    MEDICAL
    May 2016 - October 2018 (2 years and 6 months)
    Zug, Switzerland
    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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Certifications

  • IPMA Certified Project Manager
    IPMA

Skill set

Categories

  • Other