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  • Functie titel:

    Regulatory Affairs Specialist

  • Sector:

  • Job ref:

    46244

  • Start datum:

    2021-06-01

The Company 
Our client is an international organization in the Medical Devices (MD) industry with a variety of products such as orthopaedics, vision, interventional solutions and surgery. 

Role Description 
As a Regulatory Affairs specialist you will ensure compliance with local regulatory requirements, national and international guidelines. 

Responsibilities 
- Review and approval of Labels and Instructions for Use.
- Update of RA database.
- Handle all necessary activities for the release of SKU (codes) restrictions.
- Ensure regulatory compliance of MD for their access to the Benelux market.
- Identify Regulatory Issues & strategies concerning MD, in the scope of the Project, investigate and suggest solutions to resolve them.
- Provide regulatory support to ensure consistent collaboration with franchises and EMEA/ Regulatory Affairs. 


Requirements 
- MSc in Pharmacy, Biomedical Engineering or similar. 
- Similar work experience 
- Advanced user of Excel 
- Excellent communications skills in Dutch and English


Other Information 
For more information please contact Ece Karakurt at e.karakurt@sire-search.com or +31 (0) 20 658 98 01. 
 
Neem contact op

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