Company
Refined is a young biophotonics company based in Münster, Germany. Our mission is to transform cancer diagnostics and therapy by combining cutting-edge laser technology with advanced microscopy and AI. Our systems enable the detection of tumor cells within minutes – without the need for extensive biopsy processing. We aim to reduce the stress for patients and the overall cost of cancer care.
Your role at Refined
As a Regulatory & Quality Specialist, you will be responsible for building and implementing our ISO 13485-compliant quality management system and support regulatory activities related to the development of our high-tech medical products. You will work closely with internal teams, external consultants, and clinical partners.
This position bridges Quality Management (QM) and Regulatory Affairs (RA). Depending on your background and interests, you can focus more deeply on one area while contributing to the other.
Your responsibilities
* Build and implement an ISO 13485-compliant quality management system together with our team and supported by external consultants
* Support production management and executive leadership in establishing new quality processes and KPIs for high-tech manufacturing
* Assist product owners and developers in ISO 13485-compliant development processes and creation of the technical documentation for an IVDR class A device
* Support our executive team and therapy development manager in regulatory strategy and clinical study planning in collaboration with university hospitals (including two funded studies and further cooperative projects)
Your profile
* University degree in a relevant technical or scientific field (e.g., biomedical engineering, medical technology, biology, etc.)
* Prior experience in either quality management or regulatory affairs in a medical or life science environment is desirable
* Interest in both QM and RA topics, with the motivation to specialize more deeply in one area
* Basic understanding of ISO 13485, IVDR, and technical documentation for medical devices
* Structured, independent working style and strong collaboration skills
* Excellent communication in English and preferably German
What we offer
* The opportunity to build and shape a quality and regulatory framework from the ground up
* Flexible working hours, remote work options, and long-term development opportunities
* Competitive salary, 30 vacation days plus time off on Christmas and New Year’s Eve
* Individual benefits such as job bike, fitness courses, childcare support, or pension contributions
* A motivated, interdisciplinary team with open communication and regular team events
* An inspiring workplace in Münster – one of the most livable and bike-friendly cities in the world