Software MDR Consultant

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Software MDR Consultant


  Stäfa,   140 p/h

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  Regulatory Affairs    Contract

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This is the opportunity to join a world-class medical device company with the most advanced technology out on the market in their field to provide interim support for a remote based 6 month contract with possibility of extension. You will provide technical support to the project relating to SaMD regulations assisting with gap assessments for certification under MDR.

Responsibilities

  • Conduct gap assessments and project submissions for certification of approved software products under the amDD.
  • Check validity of current certification under new MDR.
  • Regular communication with teams in the California in the US to deliver on the project.

Experience required

  • 5+ years' experience working in similar functions to deliver on new MDR.
  • Experience and knowledge of high risk and implantable devices.
  • Sound Knowledge of SaMD regulations e.g. IEC 62304.
  • Located in Switzerland and fluent in English.

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Hannah.Hughes

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