QA/RA specialist

Job description

The QA/RA Associate shall provide support for the development of innovative medical devices, as part of the Spentys QA/RA team. (S)he will provide support in Quality Assurance and Regulatory Affairs activities such as, but not limited to:

  • Quality Management System implementation (writing and monitoring procedures, forms, records, instructions and documents)
  • Standards watch and gap analysis to perform when starting new internal projects
  • Watch over regulatory aspects for Spentys to start businesses in countries worldwide
  • Communicate with the team across departments
  • Lead potential projects and dispatch work in the team (ex. GDPR compliancy, ISO27001, ISO13485, etc.)
  • Compilation of documentation for notified bodies, FDA, competent authorities

Responsibilities

  • Implement, improve and maintain the Spentys procedures
  • Train the team to follow the procedures
  • Answer questions of the team regarding QA/RA aspects
  • Communicate, track, and report progress.

Job requirements

  • Min. 2 years of relevant experience in medical devices QA/RA functions
  • Good understanding of medical devices regulatory environment (MDR)
  • Good knowledge of medical devices quality assurance (ISO 13485) and relevant standards
  • Fluent in English and French or Dutch
  • Be creative, organised and motivated
  • Meticulous, understanding and comprehensible
  • Knowledge of the medical field is a plus
  • Ability to take initiative

What you'll get

  • A thriving, entrepreneurial environment in which people matter.
  • Being part of a team working on a uniquely innovative and disruptive solution oriented towards the future of healthcare.
  • Dynamic and exciting scale-up environment - you won't be a small cog in a big machine.
  • You own a crucial aspect of our business, and you will be making a real impact on the business and the quality of life of patients.
  • Opportunities to grow within the company.
  • Competitive salary and benefits package.


Additional information

  • Start: As soon as possible
  • At least for 6 months; convincing candidate will be confirmed for undetermined period