Quality and Regulatory Affairs consultant for medical devices

14 October 2019

Get in touch!

Ruth Beckers - Managing Director

rbe@qualix.be

Are you dynamic, meticulous and entrepreneurial? Are you passionate about healthcare technology and innovation? Do you get energy from thinking along with clients? Do you want to contribute to the development of products having a high impact on people’s health? …then you should keep on reading.

Qualix is the partner of innovative (in-vitro diagnostic) medical device companies for Quality and Regulatory services. We support organizations from the development phase until the market phase and beyond and are the long-term partner where they can rely on. As a QA/RA consultant at Qualix, you will help the company grow and support the increasing customer base.

We enable organizations to market their innovative devices and help them comply to legislations. Your main responsibility will be to assist customers in Quality Assurance and Regulatory Affairs on a project basis:

• Set up, implement and manage Quality Management Systems (ISO13485) within organizations

• Support customers in complying with (IVD) Medical Device legislations in order to put their devices on the market

o Advice on regulatory strategy

o Support in writing regulatory submissions

Your profile:

• Master’s in biomedical engineering, information technology or other discipline relevant to (InVitro Diagnostic) medical devices

• A first professional experience in Quality and/or Regulatory affairs is a plus

• Strong organizational skills and able to work autonomously

• Eager to learn and open mindset

• Customer-centric thinking and effective communication skills

• Able to take initiative

• Proficiency in English and Dutch or French

• At ease with Office applications

Our offer:

• A challenging project-driven job with responsibilities

• Unique chance to help grow a young company

• Coaching on the job and continuous learning opportunities

• A permanent contract with a competitive salary

Please send your CV and application letter to:

Ruth Beckers - Managing Director

rbe@qualix.be