About the job

ProductLife Group is growing and we are looking for the next member of the Medical Device international team :

Responsibilities

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO : Quality:
  • Drafting quality docs
  • SOP, WI templates
  • Handling Non Conformities on processes and material
  • Capability to handle CAPA entirely or part of it
  • Support internal and external audits
  • CE marking approval support
Regulatory:
  • Coordinating activities in order to handle Technical Documentation aspects
  • Tech file support draft
  • STED handling
  • Declaration of conformity (according to MDD and MDR)
Compliance activities:
  • Involvement approval processes:
  • EU In country registrations
  • FDA Premarket approval (510K) support
  • MDSAP support preparation.

Education

Graduation MSC or PHD in scientific matters (Engineering, Chemistry, Pharma…)

Experience

  • At least 3/5 years of experience in medical Device field (or Strictly related)
  • Experience in quality assurance and compliance activities
  • Experience in regulatory affairs
  • Experience with a PLM documentation system is highly appreciated

Skills

  • Knowledge of standards ISO 13485 : 2016 / ISO 14971
  • Knowledge of regulations MDD 93/42 - QSR 21 cfr 820
  • Entrepreneurial spirit and proactive approach
  • Organization, autonomy and ability to prioritize

Publish Date

26 August, 2021

Spontaneous Application

RAQA Specialist for Medical Devices

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

Apply