Vacancy RAQA Specialist – Enschede


Organization

20 JUN ’22: One of the most promising start-ups, which is a spin-off from a multinational, has a diverse and challenging RAQA Specialist position open. The company is developing a drug delivery system that is going to have a severe impact on treatments in the field of neurological/brain diseases like Alzheimer’s and Tumors.

Function

Treatment of these diseases is challenging as it is difficult to get working medicines in the right place at the right time. With their solution, they are creating new possibilities and chances of improvement/recovery. As the RAQA Specialist, you support the development stage with several studies and be part of brining the product to the market.

In the role, you will contribute to the strategy and work on the overview of which steps need to be taken and are already in place. This exists of diving into the existing literature on relatable studies and supporting new ones like biocompatibility and usability studies. As it is a drug delivery device, you will work not only under the Medical Devices Regulation but also those of the Pharmaceutical industry. For this, you are in contact with several internal and external stakeholders like the QA Team of the mother organisation, CDMOs, agencies, and notified bodies to get technical documentation and the whole QMS compliant with the required regulations.

Requirements

Within the organisation, there is already a high-quality awareness and extensive knowledge of Medical Devices regulations.

Therefore the ideal candidate has:

  • A BSc/MSc degree or higher in (bio)pharmaceutical/biomedical sciences, biotechnology, or a related field
  • At least 5+ years of experience with Medicinal products
  • Knowledge of Pharmaceutical and Medical Devices regulation (GMP/ISO 13485)
  • Fluent in English (verbally and written)
  • Experience in a fast-paced moving environment
  • Entrepreneurial mindset and a self-starter
  • Affinity with project management and stakeholder management

Offer

As a compensation package the organisation offers:

  • A basic salary with €58.000 as midpoint per annum
  • 25 vacations + 6 ATV days
  • Travel reimbursement / Cycle plan
  • Attractive Pension plan
  • Mobile phone
  • Year-end bonus
  • Staff association (optional)


Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Quintes Hamer
Associate | Medical Devices

+31 6 82 10 07 58
+31 23 754 86 60
q.hamer@qtcrecruitment.com