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  • Location

    Amsterdam, Netherlands

  • Job title:

    Quality and Regulatory Manager

  • Sector:

  • Job type:

    Permanent

  • Job ref:

    44405

  • Startdate:

    2020-06-24

The Company

The company is located in Amsterdam and is active in medical Devices. They have a portfolio of preventing health issues. They have a diverse product portfolio. The company is active in more than 25 countries.  
 

Role Description

We are looking for a full time Quality/Regulatory Affairs Manager for the whole product portfolio who has knowledge in regulations and other standards. You will report directly to the director. The company is a midsize Medical Device company so you will be responsible on a broad aspect. You will collaborate with the Supply Chain department but also with the Sales and R&D department.        
 

Requirements

Your qualifications & experience

  • You will be responsible for the registrations like MDD, 93/42/EEC, MDR and ISO 13485
  • Doing the total registrations and create the technical documentations 
  • Build up a network in Notified Bodies and other authorities to create a global market access
  • guide Audits with the Notified Body and other clients
Your profile:
  • Master Degree in Pharmaceuticals or Life Science related
  • 8+ years experience in similar role with a preference in Consumer Healthcare
  • punctual and solution-oriented mind set
  • Strong interest in consumer healthcare products
  • Fluent in Dutch and English 

Contact