RA Specialist

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

Contact email: c.girdwood@panda-int.com
Job ref: 19843
Published: about 2 months ago

Currently I'm exclusively collaborating with my Medtech client in Eindhoven, who are in need of an RA specialist. They are a start up and are in need of support to preparing technical documentation (technical files etc) for the notified body; and train/advise the team on RA requirements. 

Interview + offer will happen this week! 

Role:

  • Support/advise the team on writing technical documentation/reports to be submitted to notified body
  • Review or audit Quality processes/procedures and advise on improvements if possible
  • Help to train the staff on RA processes and approach
  • Provide “lecture” style support to the team to allow them to fully understand regulatory perspective for your Class IIb device in EU market
  • On vs off site: flexible; can be off-site 1-2 days each week, or 1 week on-site 2 weeks off etc.

 

Skills:

  • Must have strong EU MDR knowledge from an RA perspective (technical files and reports)
  • +10 years experience (flexible) in the Medtech sector withing RA domains (ISO13485 understanding)
  • Ideal if have experience in Class IIb devices
  • Languages: English (Dutch is a nice to have)

Can be part-time or full time role. 

Start Date: ASAP (November 1st) 

Duration: 6 months (extension possible) 

Interested? Get in touch by sending your CV to j.williams@panda-int.com or call me on +31202044502.