Aimée Ramos Email & Phone Number

Paris, FR

• Create and update technical files for CE marking according to directive 93/42 / EEC: MDs for ophthalmic surgery of classes I, Is, Im and IIa including electro-medical MDs.
• Act as liaison between internal departments, notified bodies and ANSM.
• Implement the medical device regulation 2017/745.
• Manage international device registrations: USA (FDA class I exempt 510(k)), Canada, South and Central America, North Africa, Eastern countries.
• Participate in R&D projects: risks management, monitor regulatory strategy, ensure the data are relevant and meet the requirements of the countries in which the MD is planned to be marketed.
• Validate regulatory and normative compliance of labels, IFU, promotional materials and website.

Antony

• Created and updated technical files for CE marking according to directive 93/42 / EEC: MDs for ophthalmic surgery of classes I, Is, Im and IIa including electro-medical MDs.
• Managed international device registrations (USA, Japan, Korea, Brazil, Mexico...).
• Supported regulatory compliance activities.
• Participated in the creation of DMR.
• Created and updated Quality procedures / instructions / records, quality management manual, process manual.

Région De Paris, France

-Découverte du milieu de la recherche et de l'organisation d'un laboratoire au sein d'une équipe de 7 personnes-Acquisition de compétences techniques: RT-PCR, PCR en temps réel, analyse de séquences d'ADN de patients atteints d'une malformation au cerveau

Master 2 Professionnel, Biochimie Des Matériaux Et Du Vivant

Activities and Societies: Participation à l'organisation d'un débat: "Les dispositifs médicaux de demain: comment concilier surveillance.

Master 1, Biochimie Et Biologie Cellulaire, Mention Assez Bien