QA/RA Expert

QA/RA Expert | Scinvivo

Scinvivo aims to revolutionize cancer diagnostics and care by providing medical professionals with a next-generation minimally 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 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 ISO 13485 certified QMS system, particularly by maintaining the Quality Manual.
• Responsible for external document control and risk management.
• Responsible for complaint handling, incident reporting, field action, data analysis, and resolutions regarding non-conformities and CAPAs.
• Execute internal and external audits and supplier control.
• Support the team in delivering the required documentation.
• Be the main point of contact for quality and regulatory questions.

Support FDA and CE submission:

• Support preparation of the files for submission for 510(k) approval and CE marking.
• Be the main point of contact for notified bodies.

Implementation of new requirements:

• Keep up to date with new norms and regulations.
• Assess the impact of these new norms on Scinvivo.
• Implement new requirements originating from updated norms in alignment with the management team.

Stimulate a continuous improvement culture

Your profile:

• Proven Experience: Over 5 years of experience in Quality & Regulatory (Q&R) roles within the medical technology industry. Strong understanding of regulatory processes and experience working with regulatory bodies to secure regulatory approvals.
• Entrepreneurial Mindset: A proactive and pragmatic, solution-driven approach with a strong sense of ownership and the ability to thrive in a fast-paced, dynamic environment.
• Strong Communication Skills: Excellent written and verbal communication skills with the ability to structure and present information clearly and concisely.
• Quality mindset: You will ensure that quality remains a core priority within the team, actively integrating it into all stages of the process. Build on our existing QMS to strengthen it and to facilitate our way of working.
• Passion for Innovation: A genuine interest in Scinvivo's mission and a desire to contribute to the advancement of cancer diagnostics.

We offer:

• A full-time position in our rapidly growing company.
• Unlock the potential for equity participation after one year, aligning your success with the growth of the company.
• Join a dynamic team where your contributions directly impact the growth and success of our innovative venture.
• Embrace the opportunity to grow professionally in a startup environment, where each day brings new challenges and learning experiences.
• Thrive in an entrepreneurial setting that encourages initiative, problem-solving, and a proactive approach to challenges.
• Experience a flexible work environment that values work-life balance and understands the importance of individual needs.
• Work alongside passionate professionals dedicated to revolutionising the field, fostering a culture of innovation and enthusiasm.