Regulatory Affairs Specialist

Kelly Services Switzerland

  • Date de publication :

    24 septembre 2023
  • Taux d'activité :

  • Type de contrat :

    Durée indéterminée
  • Lieu de travail :


Regulatory Affairs Specialist

For our partner in Neuroengineering, Kelly Life Sciences is looking for:

Senior Regulatory Affairs

(Permanent contract)

You will report directly to the Chief Operating Officer:

Your responsibilities:

  • Define the regulatory strategy for the medical devices under development to enter the EU, Swiss and US markets
  • Manage the interactions with relevant regulatory bodies and, as applicable, Ethics Committees pertaining to pre-market submissions and clinical study submissions for the medical devices under development
  • Supervise the medical device development activities along the defined regulatory pathways, from the Regulatory and Clinical Affairs standpoint, in collaboration with the relevant internal and external stakeholders
  • Define and maintain the Regulatory and Clinical Affairs processes within Quality Management System
  • Ensure the compliance of medical devices' Technical Documentation with the applicable regulatory requirements
  • Provide regulatory guidance and supervision to the risk management and usability engineering activities for the medical devices under development
  • Lead regulatory intelligence and post-market surveillance activities in accordance with the applicable regulatory requirements

Your profile:

  • Master's degree or PhD in Biomedical engineering or equivalent
  • + 5 years of experience in Regulatory affairs
  • Experience with class III medical devices is an asset
  • Knowledge in EU, Swiss and USA medical device regulations
  • Knowledge in MDR (EU) 2017/745, FDA 21 CFR Part 820 and ISO 13485
  • Demonstrated experience in interacting with National Competent Authorities (FDAM Swissmedic, Bfarm)
  • Fluent in English, proficiency in French a plus

Your contact at Kelly: Anaïs Mieszczak +41 22 737 12 05


  • Anaïs Mieszczak
  • Kelly Services Switzerland