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.
- 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.
- 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)