Scinvivo
Medical Technology
QA/RAExpert
Neural analysis suggests this role is
optimal for Mid+ candidates.
“QA/RA Expert at Scinvivo. Skills: Quality assurance, Regulatory compliance, Medical devices. Be the PRRC for Scinvivo. Maintain ISO13485 certified QMS system”
Industry & Context.
Solution-driven approach
What They're Looking For.
Must Have
Over 5 years of experience in Quality & Regulatory (Q&R) roles within the medical technology industry, Understanding of regulatory processes, Experience working with regulatory bodies to secure regulatory approvals
Nice to Have
Potential equity participation after 1 year
What You'll Do.
Be the PRRC for Scinvivo
Maintain ISO13485 certified QMS system
Maintain the Quality Manual
Manage (external) document control
Manage risk management
Manage complaint handling
Manage incident reporting
Manage resolutions regarding non-conformities and CAPAs
Execute internal audits
Execute external audits
Execute supplier control
Support documentation delivery
Be the main point of contact for quality
Support preparation of files for 510(k) approval
Support preparation of files for CE marking
Be the main point of contact for notified
Keep up-to-date with new norms and regulations
Assess impact of new norms on Scinvivo
Implement new requirements originating from updated norms
Stimulate a continuous improvement culture
How You'll Work.
Team & Collaboration
Quality and regulatory questions; Management team
Communication Scope
Present information clearly; Present information concisely
Full Job Description
QA/RA Expert | Scinvivo Location: Eindhoven, NL Hybrid: minimal 3 days/week at the office Reports to: CEO and co-founder Marijn van Os Compensation: Competitive salary + potential equity participation after 1 year About the Venture - Scinvivo Scinvivo aims to revolutionize cancer diagnostics and care by providing medical professionals with the next-generation minimal invasive imaging platform. This imaging platform fills the gap left by current imaging technologies, which cannot visualize tissue anatomy during endoscopic procedures. Our Lumante platform enables real-time imaging of the tissue structure below the surface. The incredible resolution, of only a few micrometres, allows the detection of very early tumours which are smaller than 1/10th of a mm. The Scinvivo imaging platform makes one-stop diagnosis and treatment possible. The Scinvivo platform aims to improve patients' Quality of Life and reduce costs for the healthcare system. As Scinvivo develops medical technology, adherence to international standards and regulations is of utmost importance for successful business introduction. Scinvivo has an ISO 13485 certified QMS system in place, and first in-human clinical trials have started this year. We are planning to file for both FDA 510(k) and CE-marking in 2026. Your Role We are looking for a highly motivated, versatile Quality and Regulatory Expert with specialized knowledge in the medical field to join our dynamic team. In this pivotal role, you will contribute to our quality management strategy and provide vital support to the team. This is an exceptional opportunity to make a meaningful impact at a company developing groundbreaking technology with the potential to revolutionize cancer diagnosis and treatment. Your Activities and Responsibilities include: Quality and regulatory: - Be the PRRC for Scinvivo. - Maintain our ISO13485 certified QMS system, particularly by maintaining the Quality Manual. - Responsible for (external) document control, risk mana
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