Quality & Regulatory Manager - Medical Devices (Permanent)

Quality Assurance/Regulatory Affairs Manager - Exciting Opportunity in Ghent, Belgium

Our client is a newer, dynamic company in the exciting stage of developing a ground-breaking surgical cancer device that will revolutionise the way breast cancer is detected and treated. You will have the unique opportunity to be part of this pivotal development phase and witness the tangible results of your hard work.

The motivated team at this company comprises individuals who believe wholeheartedly in the mission, providing a motivating environment where you can draw energy from the talented and like-minded individuals around you. In this flat hierarchy organisation, collaboration is key, with the CEO sitting amongst the team, fostering an open culture that encourages transparency and open communication.

Benefits:
- Be part of a motivated team working on a revolutionary medical device in the operating room.
- Opportunity to make a real difference in patient care by minimising the need for multiple surgeries and ensuring thorough removal of bad tissue.
- Potential to be involved in a product with significant market potential.

Responsibilities:
- Ensure compliance with ISO 13485, ISO 14971, and Regulation (EU) 2017/745 in the development and maintenance of quality management systems.
- Lead the implementation and maintenance of quality management systems to ensure regulatory compliance.
- Contribute to the design of innovative medical devices and sterile devices, leaving your mark on the product development process.

Requirements:
- Proficient understanding of ISO 13485, ISO 14971, and Regulation (EU) 2017/745.
- Experience in implementing and maintaining quality management systems.
- Fluency in English and Dutch, with knowledge of French considered an advantage.
- Previous experience with similar medical devices and/or sterile devices is highly advantageous.

If this role suits your personal and professional profile, send your CV to myself, Christian Finnegan (C.finnegan@nonstopconsulting.com), on the NonStop consulting website or to my LinkedIn. If you yourself are not interested in this opportunity however you know someone whom might be interested in a new role, please forward this job posting to them and help them expand their network.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, France, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.