QARA Specialist - IVDR / MDR

This company based in Ghislenghien, is offering a rare chance for an RA / QA Lead to join their team and make a significant impact. With a small structure and short lines of communication, you can expect direct access to decision-makers, enabling quick approval processes.

Being part of a company that focuses on diagnostic technology rather than the usual pharmaceutical or industrial sectors provides a distinctive environment for professional development, setting you on a unique career path that is not typically made available to people outside of the industry without prior experience.

Benefits :

• Opportunity to learn from a different industry and broaden your skill set
• Rare chance to work in a diagnostic company in a region with limited IVD companies
• Potential for growth and development, leading to better hiring prospects in the future

Responsibilities :

• Ensuring regulatory compliance and quality standards with ISO 13485
• Oversee quality assurance processes to maintain product safety and efficacy
• Ensure all personnel are trained on relevant QMS procedures and regulatory requirements
• Collaborate with cross-functional teams to drive continuous improvement and product excellence

Requirements :

• 2+ years of experience in a QA or RA role within the medical device or diagnostic industry
• Proficiency in French and English for effective communication within a diverse team
• Knowledge of ISO 13485 and regulatory requirements
• Notified Bodies and U.S. Food and Drug Administration (FDA)
• Risk management

If this role suits your personal and professional profile , send your CV to myself, Christian Finnegan ([email protected]), 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.