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Regulatory Affairs Specialist

Published on Jobat.be 24 days ago

Regulatory Affairs Specialist

Pauwels Consulting is a Belgian consulting firm with more than 520 experts in engineering, life sciences and IT. We offer consulting, project management and recruitment services to leading companies in Belgium and beyond. We have offices in Belgium, France, Germany and Switzerland (https://www.pauwelsconsulting.com/about/contact/) .

Job description

For a client in Diegem we are currently on the look-out for a Regulatory Affairs Specialist. As a RA Specialist you support the implementation of the procedures under the EU Medical Devices Regulation. You have the following responsibilities: 



  • Maintenance of AR agreement 

  • Verification of manufacturers compliance for new MDR products certification 

  • Complete verification measures per process

  • Verify manufacturer device data registrations

  • Notify manufacturer about gaps and requires corrections

  • Correct gaps or mistakes if needed

  • Manage AR registration related fees and invoices

  • Provide regulatory and quality support to the Supply Chain End to End EU MDR

  • Support and train the access to relevant documents and address questions

  • Ensure resolutions on non conformities by the Quality Organization

  • Manage and support QA requests such as CAPA's and Audits

  • Responsible for communicating business related issues 

  • Ensure personal and company compliance with all Federal, State, local and Company regulations

Profile

You meet the following requirements: 
  • Two to four years experience with QA/RA

  • Minimum a Bachelor degree

  • Fluent in English and another European language (French, Dutch or German)

  • Knowledge of European Regulation Medical Devices and ISO 13485

Offer

  • Challenging projects based on your interests and skills

  • Personal follow-up and clear, transparent communication both before and after commencement of employment

  • Possibility to follow extra training

  • Inspiring network events and legendary after work drinks

  • Strong network of industry leading clients

  • Expertise within IT, Engineering and Life Sciences

  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

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Pauwels Consulting | Diegem 1831

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    16 days left to apply

    Characteristics

    • Function type: Quality
    • Sector: Chemistry and Pharmacie
    • Diegem (location)

    Requirements

    • Professional bachelor (Higher Education Short Type)
    • English

    Offer

    • Permanent
    • Independent
    • Full-time
    • Company car

    Apply before

    • 2 February

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