Regulatory Affairs Specialist Junior

Posted 10 May 2022
LocationLe Vaud
Job type Permanent
DisciplineLife Sciences

Job description

For its biotechnology's partner, Kelly Life Science is looking for:

Regulatory Affairs Specialist Junior

(Permanent position)

Your mission

  • You will support the department by preparing/verifying the Medical Device Technical Documentation according to the EU Medical Device Regulation (MDR) 2017/745
  • You will ensure compliance of the labelling according to the regulation and applicable standards

Your responsibilities

  • Support the preparation of the medical device technical documentation according to EU MDR 2017/745 requirements
  • Assess the regulatory impact for the changes to existing products/development of new devices
  • Ensure accurate records of product submission and registration
  • Ensure regulatory review and update of the device labelling information
  • Support activities related to CAPA processes

Your profile

  • A Bachelor or master's degree in the medical field, life sciences or similar (or equivalent work experience in similar function)
  • Basic Knowledge/understanding of the EU Medical Device Regulation (EU) 2017/745, European Medical Device Directive 93/42/EEC and ISO 13485
  • Fluent (C1 minimum) in written and spoken English

Your contact at Kelly Life Science : Anais MIESZCZAK