Posted to MedZilla on 3/26/2017


Germany, Design Controls Subject Matter Expert QA_ND_11100-MZ


Our client is seeking a Design Controls Subject Matter Expert to join their team in Germany.

Job Role:

  • The company is currently running a project to remediate the Design History File (DHF) of several products. The products are consumable devices used in cardiac surgery.
  • The SME will work with a multifunctional design team to provide advice and guidance on plans to remediate multiple products.

Job Requirements:

  • Design History File Remediation
  • Design of Consumable devices, preferably on products which pump blood
  • 510(k) including updating existing 510(k)
  • Design Transfer
  • 21 CFR 820.30, ISO 13485
  • Risk Management to ISO 14971
  • CE Submissions
  • Preparation of STED Files
  • dFMEA and pFMEA
  • Statistical Techniques, e.g. Sample Size justification.
  • Process Validation
  • German & English language skills

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nick Dietz on +44 203 3193 033 or upload your CV on our website
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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