Scientist as Quality Management- and Regulatory Affairs Assistant - PCR, Diagnostics (m/f)

Currently we are looking to recruit a
Quality management and regulatory affairs assistant
Full time

Job description

The post-holder will assist the quality management and quality control department in various tasks such as updating and generating various documentation in accordance with different normative and regulatory requirements. You will support various customers in the registration purpose of our products in various countries.

Key responsibilities

  • Work as a member in the quality management and quality control department
  • Support the QM and QC team in the tasks of generating and updating all relevant documentation (SOP, process instructions, manuals, ...) according to the ISO 13485 and the applicable regulatory requirements
  • You assist the QM department to prepare the necessary documents for registration purpose based on regional regulatory legislations and guidance
  • You assist the QM department in the establishing and maintaining technical files
  • Plan projects and act as an interim person between different departments

Your profile

  • Bachelor degree
  • Good understanding and knowledge of ISO 13485, FDA regulations, IVD 98/79/CE (other regulations would be considered as a plus)
  • Experience in RT-PCR
  • Good knowledge of MS office
  • Fluent in English both writing and speaking, any other language is considered as an advantage
  • High flexibility
  • Communication in a clear, concise and timely manner
If you feel that our job profile matches your qualifications and personality, please do not hesitate and send us your application in English, including CV, covering letter and your expected salary, by post or email to the following address:
While applying for the job please refer to jobvector
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About Fast Track Diagnostics

Fast-track Diagnostics (FTD) Ltd develops and commercializes worldwide multiplex real time PCR (RT-PCR) assays to detect a wide range of viruses, bacteria, fungi and parasites. We are 13485 certified with most tests having a CE certificate. Our kits are used in all size labs, in the public and private sector. In the last years, FTD created a global distributor network that serves many...

More about Fast Track Diagnostics

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