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Chrispy PetntangCP

Chrispy Petntang

Quality Regulatory Affairs Medical Device

€400/day
Paris, FR
3-7 years
Risk Management
MDR 2017/745
IEC 60601
IEC 62304
Usability Engineering according to IEC 62366

Average response time: 1 hour

Freelancer profile translated to English.
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About Chrispy

Specializing in Quality and Regulatory Affairs for medical devices, holding a dual degree in Biomedical Engineering and Medical Device Regulation, I have been involved for over six years (6 years) in the entire lifecycle of medical devices.

I support companies in securing their regulatory compliance, structuring and optimizing quality management systems, obtaining CE marking (MDR), and post-market management, in close collaboration with R&D, quality, regulatory, clinical, and marketing teams.

My areas of intervention include design control, labeling management, regulatory monitoring, product risk analysis and control, complaint and non-conformity handling, change management, as well as Design History File (DHF) management.

Recognized for my ability to manage multiple projects simultaneously, I collaborate effectively with internal and external teams and contribute to team skill development through training on best practices and regulatory requirements.
Biotechnologies
Pharmaceuticals
Medical Devices
Consulting and Audits
IoT (Internet of Things)

  • French

    Native or bilingual

  • English

    Fluent

Can work on-site
Paris (up to 50km), Lille (up to 50km), Lyon (up to 50km), Bordeaux (up to 50km), Marseille (up to 50km)

Experience

  • Laboratoires Théa
    Regulatory Affairs Specialist
    PHARMACEUTICALS INDUSTRY
    May 2023 - Today (3 years and 3 months)
    Clermont-Ferrand, France
    Medical Devices (Class I, Is, IIa, IIb & Software)

    - Drafting of technical files in accordance with the Medical Device Regulation (Classes I, Is, IIa, IIb and Software) and updating technical files in accordance with Directive 93/42/EEC.
    - Qualification and classification of software in accordance with the Medical Device Regulation and regulations relating to artificial intelligence.
    - Updating Quality Management System (QMS) processes to include specificities related to software and artificial intelligence.
    - Integrating ISO/IEC 42001 requirements into development activities to ensure compliance with new AI governance expectations and regulatory requirements.
    - Participating in design reviews throughout the product lifecycle to ensure compliance with requirements, regulatory standards, and risk management, in order to support overall product quality, compliance, and readiness for industrialization and market deployment.
    - Defining the regulatory pathway for AI-based software.
    - Regulatory support for new projects (assistance and advice to R&D teams).
    - Verification and validation of documentation (planning, design, development, verification, validation, and design transfer).
    - Providing regulatory expertise during due diligence on new projects (feasibility studies, preliminary data, regulatory framework): software, machinery, and solutions.
    - Creating and updating risk management files (analyses, reports, and protocols) and integrating artificial intelligence into product risk management.
    - Drafting usability engineering files.
    - Creating/updating labels and user manuals.
    Risk Management Usability MDR 2017/745 Labelling Regulatory Compliance (MDR, IVDR, FDA, MHRA, Health Canada)
  • Macopharma
    Regulatory Affairs Officer
    PHARMACEUTICALS INDUSTRY
    May 2022 - May 2023 (1 year)
    Lille, France
    - Updating technical files in accordance with the Medical Device Directive (MDD) and preparing the technical file in accordance with the Medical Device Regulation (MDR) (Classes I, IIb and Software)
    - Creating labels and user manuals
    - Regulatory support for R&D teams in the development of new projects
    - Creating and updating usability engineering files
    - Creating and updating risk management documents (analyses, reports, and protocols)
    - Change control management
    Usability Engineering Labelling technical drawing Regulatory Intelligence Usability
  • Healthy Mind
    Quality and Regulatory Affairs Officer
    MEDICAL
    March 2022 - April 2022 (1 month)
    Paris, France
    - Updating the Quality Management System (writing and updating procedures).
    - Registering software in Canada (obtaining an establishment license).
    - Qualification and classification of new software modules.
    - Regulatory support for the R&D team in the design of new medical device modules.
    IEC 62304 Post-Market Surveillance & Vigilance Regulatory Compliance (MDR, IVDR, FDA, MHRA, Health Canada) Quality Assurance Release Management
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Education

  • Bachelor's Degree in Biomedical Instrumentation and Maintenance
    University of Mountains
    2017
  • Master's Degree in Health Engineering
    University of Technology of Compiègne (UTC)
    2020
    Option : Dispositif Médical et Affaires Réglementaires

Skill set

Quality Management
Product Development
Process Management
ISO 13485
technical file
Market-Entry Strategy
Agile Project Management
Due Diligence
Risk Management
Regulatory Compliance
Change Management
Risk Analysis and Management

Categories