Manager Quality Assurance & Regulatory Affairs EMEAI | The Netherlands

Bachelor | University   Fulltime   Alphen aan den Rijn


Alphen aan den Rijn
Bachelor | University
Fulltime
Sakura Finetek Group is an international manufacturer and supplier of first-class, high-quality medical diagnostic products.  We develop, manufacture, and sell histological and cytological instruments and consumables. To gain a better understanding of what we are achieving, please check www.sakura.eu
 
We have achieved our success and solid reputation by providing timely, well-thought-out solutions to help solve the everyday challenges faced by laboratories. Currently, about 250 staff members work at our various locations throughout Europe. This is Our Story.

At the moment, we are looking to employ an ambitious

Manager Quality Assurance & Regulatory Affairs EMEAI
The Netherlands

 

The position

Initiating, maintaining, and ensuring that the Quality Management System complies with ISO 13485 and international medical device regulatory standards, that's what this role is all about. This means overall compliance with IVD / Medical Device Directives and CE Marking.
 
Creating quality awareness and continuous improvement are perfectly safe in the hands of a true professional. A personality who is in control when it comes to compliance and inspirational when it comes to collaboration.

In this role, you report directly to the VP Customer Operations with a dotted line (Vigilance) reporting to the Managing Director | General Manager.

 

You are

  • managing the QA& RA team (3fte)
  • responsible for QMS, ISO 13485 compliance, and certification
  • leading Complaints Management, pMDR, CAPA, and Management Review
  • responsible for regulatory compliance, certification, and product registrations of all products
  • keen and able to collaborate with our 15 offices and entities throughout Europe
  • the liaison Quality and Regulatory Affairs for Sakura Finetek USA & Japan 
 

You have

  • what it takes to bring quality and compliance to the fore and a relevant Master’s degree
  • industry experience of working within the MDD and/or IVD regulatory affairs area
  • solid working experience with ISO 13485
  • at least 5+ years working experience in an international technical service/support environment
  • excellent leadership skills and the ability to encourage and motivate people
  • an analytical mind, the ability to adapt, and a social attitude
  • the drive to improve!
 

You

  • live in Europe (The Netherlands) and feel at home in an international environment
  • enjoy building strong working relationships with your colleagues and other stakeholders
  • know how to communicate at all levels
  • can express yourself fluently in English, both verbal and in writing
  • are willing to travel for approx. 10% of the time
  • reach out, team up and deliver!

The invitation

Would you like to be part of a healthy, privately owned company and an ambitious team? Our culture is a friendly and open one. We believe that the development of our people enables the company's growth.

Sakura offers an interesting employment package, including a gross yearly salary of approximately €80.000, - (including 8% holiday pay) an attractive bonus structure max. 15%, a company car, a fully paid pension plan, a daily freshly prepared lunch, and a gym discount.

Most importantly we are interested in what drives you to be successful!


Interested in speaking to us?

Does the above appeal to you? Apply today by using our Online Application Form.

If you have further questions or would like more information about this job, please contact Paul van der Hove (Recruitment), p.vanderhove@sakura.eu.

Acquisition to this vacancy is not appreciated.
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Sakura Finetek Europe B.V.

Flemingweg 10a
2408 AV  Alphen aan den Rijn

Contact
Recruitment
Paul van der Hove