Claudia-Rose Mastrobuoni

Regulatory Affairs and QA Manager at RICHARD WOLF UK
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Contact Information
us****@****om
(386) 825-5501
Location
UK

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Credentials

  • Introduction to ISO 13485:2016
    LRQA

Experience

  • RICHARD WOLF UK
    • United Kingdom
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs and QA Manager
      • Jan 2022 - Present

      UK Responsible Person (UKRP) working with UK, EU and International Medical Devices Legislation. Quality Manager and Representative responsible for the implementation of ISO 13485:2016 requirements. UK Responsible Person (UKRP) working with UK, EU and International Medical Devices Legislation. Quality Manager and Representative responsible for the implementation of ISO 13485:2016 requirements.

  • Thermo Fisher Scientific
    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Regulatory Compiler
      • Oct 2021 - Jan 2022

      Working on requirements for IVDR projects including: gathering documentation; creating technical files; overseeing transfers between distributors; responding to information requests from international clients; overseeing renewals; assisting in literature reviews for CER’s and updating SOP’s. Working on requirements for IVDR projects including: gathering documentation; creating technical files; overseeing transfers between distributors; responding to information requests from international clients; overseeing renewals; assisting in literature reviews for CER’s and updating SOP’s.

  • Phagecon - Pharmaceutical Services and Consulting
    • Portugal
    • Pharmaceuticals
    • 1 - 100 Employee
    • Pharmaceutical Intern
      • Jul 2020 - Sep 2020

      Gave support to the Business Development Manager including benchmarking, identifying content, preparation of marketing and social media campaigns and reviewing institutional communication. Gave support to the Business Development Manager including benchmarking, identifying content, preparation of marketing and social media campaigns and reviewing institutional communication.

  • Hambleton UK Ltd
    • Preston, England, United Kingdom
    • Quality Control Executive
      • Mar 2019 - Jul 2020

      Quality Assurance and Pharmacovigilance for pharmaceutical wholesaler. Involved in the management of quality systems, processes, and procedures to ensure product quality and safety as well as performing regular audits of suppliers and customers. Kept up to date with product recalls and supplier licences. Involved in the evaluation of change control proposals and implementation of CAPAs. Quality Assurance and Pharmacovigilance for pharmaceutical wholesaler. Involved in the management of quality systems, processes, and procedures to ensure product quality and safety as well as performing regular audits of suppliers and customers. Kept up to date with product recalls and supplier licences. Involved in the evaluation of change control proposals and implementation of CAPAs.

  • Rhodes Pharma Ltd
    • Preston, England, United Kingdom
    • Medical Devices- Marketing Executive
      • Mar 2019 - Jul 2020

      Involved in planning and executing marketing campaigns including advertising in medical journals and digital promotions. Generate sales analysis and targeting reports. Involved in the presentation of clinical data considering the importance of accuracy and ethical representation of pharmaceutical products. Included the storage and handling of Safety Data Sheets/Certificates of Analysis, Involved in planning and executing marketing campaigns including advertising in medical journals and digital promotions. Generate sales analysis and targeting reports. Involved in the presentation of clinical data considering the importance of accuracy and ethical representation of pharmaceutical products. Included the storage and handling of Safety Data Sheets/Certificates of Analysis,

  • Kensington Pharma Ltd
    • Preston, England, United Kingdom
    • Regulatory Affairs
      • Mar 2019 - Jul 2020

      Worked with the regulatory department to design pharmaceutical packaging, labelling and patient information leaflets. Worked with the regulatory department to design pharmaceutical packaging, labelling and patient information leaflets.

Education

  • University of Lisbon
    Master of Science - MS, Regulation and Evaluation of Medicines and Health Products
    2020 - 2022
  • Oxford Brookes University
    Bachelor of Science - BSc, Biology, General
    2015 - 2018

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