Vacature: Senior Regulatory Affairs Specialist | The Netherlands Vacature - Alphen aan den Rijn, (Select) 2408 AV
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Senior Regulatory Affairs Specialist | The Netherlands
Sakura Finetek Europe B.V.
Quality Control / Security / Safety
Alphen aan den Rijn
40 hour
Bachelor - University




Sakura Finetek Europe B.V.

  Quality Control / Security / Safety
   Alphen aan den Rijn
  40   
Bachelor - University
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. A testimonial. 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

Senior Regulatory Specialist | The Netherlands
Alphen aan den Rijn 

The position

Being responsible for the overall regulatory compliance of Sakura’s products, that's exactly what this role is all about. Acting as a liaison between Sakura Finetek Europe and local and international authorities to submit required documentation.
 
Creating regulatory awareness and continuous improvement are perfectly safe in the hands of a true professional. A personality who is in control when it comes to Regulatory Affairs and inspirational when it comes to collaboration with 15 Sakura offices and entities throughout Europe
 
In this role you join the QA&RA Team, collaborating with stakeholders within and outside of our matrix organisation reporting directly to the Manager Quality Assurance & Regulatory Affairs EMEAI

 

You are

  • ‘The Expert’ in the regulatory domain (IVDR)
  • responsible for all technical documentation and the EU declaration of conformity are drawn up & kept up to date
  • initiating and maintaining registrations in the European database for IVDR (EUDAMED)
  • reporting on compliance status and measuring in- and external parties
  • managing compliance to all relevant directives (WEEE, REACH and ROHS)
  • the liaison Regulatory Affairs for Sakura Finetek USA & Japan
  • acting as the Person Responsible for Regulatory Compliance (PRRC) as laid down in the 2017/746 IVD Regulation, article 15
 

You have

  • what it takes to bring RA and compliance to the fore and a relevant degree
  • a deep understanding of medical products and services
  • experience with ISO 13485, WEEE, REACH and ROHS directives
  • industry experience of working within the MDD and/or IVD regulatory affairs area
  • 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. 30% 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 €70.000, - (including 8% holiday pay) an attractive bonus structure max. 8%, 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. Website: Go to website

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Acquisition? Please don't!

Contact information
Sakura Finetek Europe B.V.
Paul van der Hove
Flemingweg 10
2408 AV Alphen aan den Rijn

Website: Go to website