QA/RA Associate (PhD)

GenDx, experts in transplant diagnostics

GenDx is a global leader in molecular diagnostic solutions for matching donors and patients and monitoring transplant success. We combine our cutting-edge software and reagents for Sanger & Next Generation Sequencing HLA typing and Chimerism monitoring with excellent customer support and education. Together with a highly educated and motivated team of approximately 60 people, we contribute to the quality of life of transplant patients. Do you want to be part of an innovative company that offers excellent working conditions and ample time for personal development?
To strengthen our team, we are looking for an

accurate and quality-driven
QA/RA Associate (PhD)
who can translate R&D and regulatory principles into product development and registration

As QA/RA Associate at GenDx, you understand that high-quality products are rooted in R&D. Being part of the QA/RA team, you are responsible for the registration of our products by exploring which regulatory principles apply and discussing which R&D the tests which are necessary to realize this, which includes writing of related documents. In doing so, you are enabling product development, sales, and a viable workplace for your colleagues.

Responsibilities

  • Interpreting and implementing regulatory legislations and guidelines.
  • Supporting the provision of regulatory guidance regarding R&D and marketing of products.
  • Preparing and submitting applicable dossiers to regulatory authorities.
  • Preparing, developing, reviewing and maintaining QA/RA documents.
  • Supporting activities such as internal and supplier audits.
  • Working according to ISO 13485 standards and IVDR directives.

Requirements

  • PhD in Molecular Biology or equivalent.
  • Focused and well-organized workstyle.
  • Outstanding in keeping overview, ensuring timelines, accuracy and comprehensiveness.
  • Excellent command of Dutch and English (both written and spoken).
  • You live in the Utrecht area, or are willing to relocate.

Information
For more information you can contact Erica Kremer PhD, Quality Assurance Officer or Maarten Penning PhD, CTO, +31 30 252 37 99.

Do we match?
Send your CV and motivation to Roelien Brommersma MSc, CHRO, hrm@gendx.com. Please mention ‘2020_02’ and your name in the email subject line.

Unsolicited third party/agency profiles and resumes will not be considered.