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Remote Regulatory Specialist IVD - Leading Diagnostics Company

Business Type: Biotechnology Company, Diagnostics Company
Job Type: Regulatory Affairs
Job Level: Experienced (non manager)
Position: Full Time
Location: Ireland (Eire)
Reference: RS.295050.3
Closing Date: 23/07/21
Job Details:

Regulatory Affairs Specialist IVD - Leading Diagnostics Company - Remote

Job Summary:

Are you trying to take the next step in your career as a Regulatory Affairs professional within Medical Devices/Diagnostics field?

My client, an absolute industry giant, is recruiting a remote/office Regulatory Affairs Specialist for their Danish team. This role is a great opportunity for people who want to work with the latest technologies in the field, and to be a part of one of the most successful companies in the Diagnostics and Life Science industry. In this role, you would be dealing with advanced cancer diagnostics products and technologies, applying your experience and developing your understanding of the regulatory norms and normative environment. Possibly no other company in the field offers development opportunities that my client offers, providing both horizontal and vertical career movement opportunities. A consistent internal training program will ensure you continue evolving and improving in a flexible, supportive environment. Their high overall retention rate proves that the organisation provides everything necessary for an ambitious Diagnostics professional to thrive and succeed in the long term.


Job Tasks and Responsibilities

  • Developing and implementing regulatory procedures in accordance with the EU IVD regulation
  • Ensuring the compliance of the technical documentation and NB certification of IVD products for cancer diagnostics
  • Compiling STED files for regulatory submissions required for IVDR certification and new country registrations
  • Working in new product development processes, managing strategies, submissions, license renewals and annual registrations
  • Reviewing product and marketing materials to satisfy regulatory needs
  • Representing the company towards notified body and authorities

Qualifications and requirements:

  • A degree in a relevant field (biochemistry/engineer/law/etc.), combined with regulatory experience
  • Certification in a specialised relevant area is considered a plus
  • Developed knowledge and proven experience of EU MDR and/or IVD Regulation
  • Ability to interpret regulations and standards in relation to specific products
  • Understanding of design controls and in depth knowledge of relevant standards (ISO 13485, 14971, 62366, 23640, etc.)
  • Experience with audits from regulatory authorities and EU notified bodies
  • Fluency in English language, knowledge of Danish is merited
  • Limited travel obligations

If You are interested in the position, don''t miss out on this fantastic career opportunity and contact:

Radovan Sević: Phone: +44 207 940 2100, Internal Extension: 3348,

If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!

Posted: 16/07/2021 | NPJ Ref: 275692 | NPJ Original URL
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