Christian Micheletti

Senior Regulatory Affairs Manager

Zurich, Switzerland

About

Experienced Project Manager with a demonstrated history of working in both R&D and consulting industry. Skilled in Risk Assessment, Regulatory affairs, Nanosafety, Research and Development (R&D). Strong program and project management professional with a PhD focused in Ecological risk assessment from Università Ca' Foscari di Venezia.

Experience

  • Senior Regulatory Affairs Specialist at medmix
    Sep 2023 - Present · 3 yrs 2 mos

    • Created and maintained technical documentation for Class I medical devices in dental and surgery. • Supported registration processes for devices across multiple markets, including the EU, UK, Brazil, China, and South Korea. • Conducted biological evaluations of product groups and assessed labeling content. • Established standard management processes and tools, contributing to product stewardship initiatives.

  • Regulatory Affairs Project Manager at TEMAS Solutions
    Oct 2020 - Present · 6 yrs 1 mo

  • Regulatory Affairs Manager at Nouvag AG
    Oct 2020 - Sep 2023 · 3 yrs

  • Project Manager at TEMAS AG
    Feb 2018 - Jun 2020 · 2 yrs 5 mos

    Consulting companies on regulatory affairs and risk assessment. Safe-by-Design platform application and implementation. Active in different regulated products fields, such as Medical Devices, Novel Food, Cosmetics, Food and Cosmetics packaging.

  • Senior Researcher at EcamRicert - ECSIN
    Nov 2015 - Jan 2018 · 2 yrs 3 mos

    Nanosafety, Regulatory Risk Assessment, Consultancy, Regulatory affairs.