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  • Location

    Rotterdam, Gemeente Rotterdam, South Holland

  • Job title:

    Interim QARA specialist

  • Sector:

    Medical Devices

  • Job ref:

    46362

  • Start Date:

    2021-08-02

Company

The company is active in everyday healthcare products in the field of cosmetics, medical devices and medicines. Their products are available in over 50 countries worldwide.

Job Description

Acting as Quality operations specialist for Medical device and cosmetics in relations to production and release of medical devices. Acting as CMO responsible for a portfolio of consumer healthcare, which includes medical devices (MD), cosmetics (CS) and food supplements.

Acting as Specialist for business quality in the global department as well as a specialist in the BENELUX region managing complaints, transports 3PL management and local processes as well as provide eventual support to the DACH region. Act as local RA specialist for the consumer healthcare portfolio.

Responsibilities

  • Quality Assurance
  • Production and release of MD
  • Change control of MD
  • Data and documentation compliance of MD and CS
  • Primary sparring partner for RA colleagues in RA consumer healthcare
  • Complaints and root cause assessment from market and assigned portfolio
  • Local compliance BENELUX and potentially DACH
  • Other affiliate Scientific Affairs tasks may be included
  • Labeling compliance and mock-up review
  • Local regulatory specialist answering to local FAQs on the consumer healthcare portfolio and be liaison to global RA.

 

Requirements

  • Bsc
  • 1 year qa or ra experience within a life sciences company
  • Able to work on site in Rotterdam
  • Fluent in English and Dutch mandatory

Good to know: This role is open for a temp-to-perm construction.

Contact us

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804