Experience

Dreem

• France
• Hospitals and Health Care
• 1 - 100 Employee

• Regulatory affairs project manager

  • Jan 2022 - Present

  - Collaborate with cross-functional teams such as R&D, Quality, Product, and Legal to ensure that the design and development activities are performed according to the regulatory strategy and regulatory requirements (regulations and guidelines) - Overseeing the planning, coordination, and management of regulatory submission/documentation activities, for new products and/or product changes, to ensure timely approvals while in compliance with applicable requirements and regulations - Review and interpret relevant regulations, standards, and guidelines - Be involved and support R&D team activities related to design and development. - Provide feedback and on-going support to the R&D and Product teams to resolve usability issues related to the medical device, and questions from regulatory agencies - Stay up-to-date on changes to regulatory requirements and provide guidance to internal teams - Be involved in the company in interactions with regulatory agencies, such as audits, inspections and negotiations - Update local databases and registrations following marketing approval - Assist quality manager on quality activities related to design and development/technical files, including change control activities - Participate in risk management activities related to regulatory compliance Show less



Pixium Vision S.A.

• France
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Lead Product Engineer

  • Sep 2016 - Jan 2022

   Industrialization process leader on the Retinal Implant Set: o Cleaning and assembly of the non-sterile set o Design transfer leader, weekly call  Production leader of the Retinal Implant Set o Weekly call of the implant semiconductor manufacturing process, routine and process development o Management of the chip production before cleaning and assembly o Management of the non-sterile and sterile Retinal Implant Set production o Support to clinical team : system improvement, surgeon training  Management and constant improvement of in vitro lifetime tests of subretinal PRIMA implants (scientific paper https://doi.org/10.1088/1741-2552/ab8f70): o Continuous monitoring and management of complex study involving multiple set-ups and tests over a long period of time o Opto-electronics testing to assess the electrical performance of the implant o Lifetime data analysis with Weibull++ software  Leader Qualification and validation studies related to Retinal Implant Set o Cleaning validation process, biocompatibility o Stability study, shelf-life, sterilization process validation o MRI compatibility per ISO/TS 10974  Team management (technicians): team trainings, planning management  Work in a strict quality system in conformity with regulatory requirements of active implantable medical devices, ISO 13485  Strong commitment: support to Quality and Regulatory team, laboratory responsible, chemical safety and ESD responsible, member of Covid task force team Show less



Pixium Vision S.A.

• Ingénieur assistant (internship)

  • Feb 2016 - Jul 2016



Phelma - Grenoble INP

• Etudiant

  • Sep 2013 - Jul 2016



Uppsala University

• Sweden
• Higher Education
• 700 & Above Employee

• Intern in Materials and Medicine

  • May 2015 - Jul 2015

  Developing a biphasic calcium phosphate cement (CPC) with increased degradation rate. It mainly consisted in designing and characterizing new low temperature self-setting multiphasic CPCs with increased degradation rate. All CPCs are obtained by mixing water or aqueous solution with blends of alpha-TCP, MCPM and beta-TCP at different molar ration. Developing a biphasic calcium phosphate cement (CPC) with increased degradation rate. It mainly consisted in designing and characterizing new low temperature self-setting multiphasic CPCs with increased degradation rate. All CPCs are obtained by mixing water or aqueous solution with blends of alpha-TCP, MCPM and beta-TCP at different molar ration.



Air Liquide

• France
• Chemical Manufacturing
• 700 & Above Employee

• stagiaire

  • Jun 2014 - Jul 2014