Freelancer profile translated to English.
Back to original languageAbout Nicolas
Genika was designed for you, with a clear ambition: to give you the keys to progress.
For nearly 20 years, my various experiences have shown me that certain subjects are poorly, or even inadequately, addressed in companies of all sizes. I therefore decided to found Genika, your risk management partner.
This activity is broken down more specifically into our different areas of intervention:
- Auditing, internal or external
- Quality, which we divide into three major themes: subcontracting management, transition management, and crisis management
- Regulatory Affairs in the field of Medical Devices, including CE marking, sterilization, and export
Our approach is simple and comprehensive: we can undertake operational missions, provide training for your teams, or more broadly support them through coaching.
Our commitment: to relieve you mentally of these subjects from the very beginning of our intervention. Focus on your business, let us handle what is not.
Together, we transform your risks into controlled decisions: that is Genika's mission.
English
Native or bilingual
Italian
Native or bilingual
Spanish
Conversational
German
Conversational
French
Native or bilingual
Chinese
Basic
Can work on-site
Le Havre (up to 50km), Paris (up to 50km), Lyon (up to 50km), Rouen (up to 50km), Marseille (up to 50km)
Experience
- GenikaConsultantJuly 2025 - Today (1 year and 1 month)Areas of activity: strategic consulting, executive coaching, auditing, surveillance, crisis management, problem-solving, transition management, quality, subcontracting management, medical device regulatory affairs, CE marking, sterilization, cleanroom
- AMI AUTONOMIEInternational Business LeaderNovember 2024 - Today (1 year and 9 months)Two parts to this mission:
- Financial recovery of the business
- Business development, particularly internationally
- DidacticQuality & Regulatory Affairs Director - PartnerMay 2017 - October 2024 (7 years and 5 months)
- Leader of product design (Class IIa sterile Medical Device – gravity infusion set)
- Management since 2020 of the Group's major industrial relocation project from China to Normandy, from preliminary project to ramp-up phase, including financing and industrial transfer
- Director of the Group's 10-year Quality & Regulatory Affairs Strategy and Roadmap (over 800 references, 4000 clients in over 50 countries, Manufacturer, Importer, and Distributor statuses)
- Responsible for ISO13485, ISO9001, MDD, MDR, and PPE certifications
- Responsible for Intellectual Property
- Responsible for relations with Authorities (ANSM, MHRA, etc.) and Notified Bodies (Bureau Veritas Italy, DNV, ECM, Satra, UL)
- Building and Managing teams: up to 3 hierarchical levels, 10 permanent staff for the Q&AR department, including one person in China
- Management of ethylene oxide sterilization (on-site)
- Launch and management of the Group's CSR strategy
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Education
- Green BeltGreen Belt
- Civil Engineer from MinesÉcole des Mines (Saint-Étienne)2008Gestion de production, Management, Sécurité & Informatique
Certifications
- Business CreationCRA2025