Freelancer profile translated to English.
Back to original languageAbout Stéphane
I specialize in supporting startups, SMEs, and large companies in the medical device sector on quality and regulatory affairs issues for over 10 years.
I have carried out numerous missions for the implementation or maintenance of management systems, obtaining or maintaining CE marking, and transitioning to Regulation (EU) 2017/745.
With solid regulatory and quality skills, as well as project management expertise, I offer you my adaptability and efficiency to support you in your various projects.
If your concerns include the following topics, I am the right person for you:
- Implementation or maintenance of a QMS adapted to your context
- Compliance of your medical devices, including software, according to MDR 2017/745, particularly standard IEC 62304.
- Management of product development in an agile environment.
- Responses to non-conformities and CAPA management
- Risk management
- Usability
- Clinical investigation
- Regulatory watch
- Transition management
Do not hesitate to contact me so we can discuss your project and explore possible solutions together.
French
Native or bilingual
English
Fluent
Can work on-site
Angers (up to 50km)
Experience
- Yoolearn 24Managing Partner - MD BetterAskMEDICALMarch 2024 - Today (2 years and 3 months)Paris, FranceI bring my expertise in quality and regulatory affairs by collaborating closely with teams such as R&D, product, marketing, and clinical services to meet medical device compliance requirements.I help management define regulatory strategies, whether for obtaining CE marking or for responding to non-conformities following an audit or inspection.
- WilloHead of QA/RAApril 2018 - March 2021 (2 years and 11 months)Paris Metropolitan Area, France
- DreemQA & RA ManagerSeptember 2016 - August 2018 (1 year and 11 months)Paris Metropolitan Area, FranceRegulatory strategy Regulations regarding the protection of personal and health data
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Education
- Engineer's degree, Biomedical/Medical EngineeringISIFC2014Engineer's degree, Biomedical/Medical Engineering
- Bachelor of TechnologyUniversité des Montagnes2010Bachelor's Degree, Biomedical Technology