About the job

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

About us

Group 10
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.

Group 11
Education

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

Group 12
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

Group 13
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

RAQA Specialist for Medical Devices