We are currently partnered with a fastest-growing global diagnostic companies and a market leader in the areas of Molecular Diagnostics and Clinical Diagnostics. The company offer a range or high-end instruments into both the clinical and industry settings with a focus on areas such as Immunoassay Systems & Immunoanalyzers, Automated Molecular Analysis, Molecular Diagnostics Instruments (PCR), Autoimmunity and supporting consumables & reagents. This global company has a smaller, close-knit team overseeing the BeNeLux region and it is this group who are now looking to bring in a Quality Assurance & Regulatory Affairs Manager to implement and maintain the quality management systems for both new product introduction and the current product portfolio. Key Responsibilities: Maintain and simplify the quality management system following the requirements outlined in ISO9001 & ISO13485 standards Train and assist all employees on the quality management system, company processes and QMS procedures and to promote the awareness of customer requirements throughout the organization. Ensure the correct handling and validation of all customer complaints, credit notes and back shipments Report to management on the performance of the quality management system, advice management on quality related improvements/changes. Reports of KPI’s, analysis of complaint statistics, credit note statistics, returned product statistics with a view of simplifying the QMS Perform internal department audits and follow up corrective and preventive actions. Initiate actions in the event of non-conformity related to product and services, providing solutions on quality improvement whilst ensuring all quality records are up to date. Update and maintain the risk management file: establishing risk acceptability criteria, risk analysis, risk evaluation, risk control and monitoring. To destroy stock (Expired, damaged, quarantine, instruments, biohazard waste) in cooperation with F&A department according local legislation. Supervising delivery or installation of non-conforming products whilst supervising the quarantine area Follow up of regulatory requirements BE, NL and LU and assure availability of valid standards or directives applicable for Menarini Benelux N.V. Keep legal and technical files up to date per product line. Requirements: Bachelor’s degree in Business Administration, Business Operations, Quality Assurance, Six Sigma Certification or similar At least 3 years’ experience in Quality Assurance or Regulatory Affairs roles within the life sciences A deep understanding of ISO standards including ISO13485 & ISO9001 The ability and understanding to implement local regulatory requirements related medical devices and/or IVD medical devices. Able to communicate and motivate via written media Must be adept in use of MS Office, particularly Excel, Word, Adobe Acrobat, Visio, internet and email and in-house specific computer software. Driven by a commitment to high-quality standards within a commercial environment, Fluent in oral and written Dutch and English An understanding of oral and written French would be preferable but not essential What's in it for you: A competitive base salary Growth opportunities with a pathway to Quality Lead role Company Car Health insurance Phone & Internet subsidy If you are interested in a call to discuss further please apply or forward your resume directly to