QA/RA manager

Job Title: QA/RA Manager     IMPORTANT:    Please kindly send your resume and cover letter in a single file to  recruitment@qurin.com . Applications with a cover letter will get more attention!    
Company Overview:   Qurin is an innovative Health tech startup based in Leiden, dedicated to revolutionizing early cancer detection through cutting-edge diagnostic technologies. With a strong scientific foundation and a clear vision to make non-invasive, accurate cancer diagnostics widely accessible,  Qurin is currently advancing its first product towards commercialization.  As a start-up, Qurin offers a dynamic environment that demands creativity, resilience, and strategic thinking.     Position Summary:   As QA/RA manager, you will be the representative of the executive management and responsible for the Quality Management System (QMS). You will further improve the QMS and work closely with the Head of IVD Assay Development to document the design & development of Qurin's products. Qurin has an electronic QMS and is almost paper free.  Given Qurin's current pre-commercial stage, this role calls for a self-starter who thrives in dynamic environments and is willing to bring Qurin’s QMS to certification under ISO13485.   You will operate at the intersection of science, business, and regulatory compliance. Developing with the team the manufacturing and QC procedures, while keeping an eye on the evolving regulatory landscape. Conducting management reviews, setting up training courses, organizing internal audits and solving CAPAs and NCs. Take the lead role in external audits, conducting audits of critical suppliers. The QA/RA manager will have a role which includes responsibility for Document Control and Risk Management.       Purpose and Scope   The QA/RA manager will contribute to Qurin's growth by driving the development and approval of its first in vitro diagnostic (IVD) product under the EU IVD regulation (IVDR). A key focus will be obtaining and maintaining ISO13485 certification and maintaining compliance of Qurin’s eQMS. The scope of Qurin under the ISO13485 certification will be design, development and manufacturing of in vitro diagnostic medical devices based on omics technology in liquid biopsy covering diagnostic assays, pre-analyticals and SiMD.     Key Responsibilities   Regulatory Affairs  

• Lead regulatory compliance activities related to Qurin's first diagnostic product in oncology. 
• Form and shape Qurin’s QMS to obtain ISO13485 certification and maintain this. 
• Arrange the regulatory requirements for placing Qurin’s product on the market 
• Contact person for regulatory affairs with Qurin’s Notified Body 
• Person Responsible for Regulatory Compliance (PRRC) 

    Quality Assurance  

• Arrange the documentation required for quality assurance 
• Train employees on Quality Assurance 

Document Control  

• Organize document, change and version control. 
• Organize the design history files, device master records and device history records 

Risk Management  

• Work closely with the team to set up and maintain Risk Management for the products under development and maintain the Risk Management Cycle 
• Implement ISO14971 on the above-mentioned Risk Management 

What We Are Looking for  

• Degree (BSc, MSc or PhD) in life sciences, biomedical engineering, biotechnology, or related field. 
• Minimum of 3 years' experience in Quality Assurance and Regulatory Affairs, preferably within diagnostics or medical device industry (IVD or MD). 
• Proven track record in organizing a Quality Management System under ISO13485 
• Experience with submission(s) under IVD-D and/or IVD-R, FDA 21 CFR and preferrable IEC 62304 
• Knowledge of Document Control and Risk Management 
• Fluent in English; proficiency in Dutch is a plus. 
• Located near, or willing to travel to, Leiden. 
• Applicants must have the legal right to work in the Netherlands. Qurin can provide visa sponsorship for candidates who are already residing in the Netherlands. 
• Available to work in the office at least 3 days per week; a part-time contract is negotiable  

Competencies and Working Style  

• Entrepreneurial mindset with a proactive, hands-on approach. 
• Comfortable navigating ambiguity and shaping strategy in a fast-evolving startup. 
• Strong interpersonal and communication skills; capable of engaging diverse stakeholders. 
• Analytical and strategic, with the ability to translate scientific innovation into regulatory compliance. 
• Value-driven and aligned with Qurin's commitment to innovation, patient impact, and collaborative growth. 

What We Offer:   • Beautiful office at the Bio Science Park, Leiden, with brand new labs.    • Inspiring work environment with supportive and talented colleagues.   • Competitive salary and pension plan.   • Personal Development Budget up to EUR 3.000 per year.   • Ability to grow with the company.   • Flexibility to manage your day-to-day work.     Are you still wondering if this is something for you? – Please do reach out and we’re happy to have an informal chat. Applications can be made to recruitment@qurin.com   For agencies – No thanks!