QA/RA Specialist

Location Netherlands
Discipline: Medical Device
Job type: Temporary/Freelance
Contact name: Caitlin Girdwood

Contact email: c.girdwood@panda-int.com
Job ref: 15096
Published: about 1 month ago

My client is a consultancy which is working with several small/medium size Medtech companies across EU and US; and are in need of additional support from a QA/RA freelancer.


Role:

  • Work together with team on several different projects, supporting MedTech Companies across EU.
  • This includes: supporting start-up and scale-up companies getting product to market; analysis of product proposition; setting up trials; Notified Body Management; audit preparation.
  • Work on company QMS (set-up/remediation) to ensure in compliance with ISO13485
  • Can be located in Netherlands, Germany, Austria or Belgium and work remotely from these regions. May be required to go on-site for infrequent client visits.

 

Profile:

  • Strong expertise in ISO13485 and must have at least 3 years experience in Medical Device Company.
  • Hands-on experience constructing and remediating QMS with auditing expertise here.
  • Experience conducting Clinical Investigations ISO14155; and working with Risk Management.
  • In-depth understanding of MDD requirements, MDR and IVDR are a plus
  • Can work in cross-functional teams, good communicator
 

Start Date: November 2021

Duration: 12 months (extension possible)