BEC Medical GmbH | Germany | 39xxx Magdeburg | Permanent position | Full time | Published since: 18.02.2026 on stepstone.de
Innovative Quality Manager / Regulatory Affairs Manager Medical Devices (Human)
Innovative Quality Manager / Regulatory Affairs Manager Medical Devices (Human) Be part of BEC Medical – where Hightech meets clinical practice. BEC Medical GmbH is a young, dynamic start-up at the STIMULATE research campus in Magdeburg and part of a strategic innovation partnership with university medicine. Together we develop one of the most modern platforms for medical robotics and artificial intelligence in Europe. Our goal: With modular, AI-assisted robotic systems to lift the precision, safety and efficiency of surgical and interventional interventions to a new level – and thus to improve health care sustainably. We combine top research, high-tech development and an agile team with hands-on mentality. With us you work on solutions that set standards worldwide and benefit patients directly. We rely on top performance, team spirit and an environment where everyone and everyone can grow beyond themselves. This dynamic is challenging – and that's what makes us feel. Who we are looking for We build security and compliance as a product function – pragmatic, data-based, human-centred. Instead of checking lists “from outside” you work with the teams, translate regulation into lean processes and good decisions and allow speed with certainty. You love modern development (software, robotics, data) and bring order into where innovation happens. In our highly agile high-tech environment, complex regulatory requirements – from MDR to FDA to AI Act – and a high standard of structured, precise and modern documentation await you. We are particularly pleased with people who have started their professional path in software development and have developed further in terms of quality, safety and regulatory management. Your technical understanding combined with regulatory know-how makes you an ideal addition to our team. .
* After clicking the Read more button, the original advert will open on our partner's website, where you can see the details of this vacancy and contact information. If you need a translation of this text, after returning to our website it will be prepared and you can read it by clicking the Show full translation button.
Your tasks • Your profile • What we offer
Care and development of a risk-based, slim quality management system (ISO 13485, AI Act). It applies: “as much as necessary, as little as possible” Responsibility for compliance with regulatory requirements for active medical devices, sterile products and medical device software / Software as a Medical Device You prepare registration and registration processes (EU/MDR, USA/FDA; incl. software/SaMD), coordinate them and make requirements for all understandable and implementable. Communication with authorities, notified bodies and external partners You design modern documentation and risk assessments (e.g. modular, slim, comprehensible) as a real knowledge base Responsibility for the implementation of regulatory tasks in cooperation with development, production and service teams Responsibility for internal audits and external audits Active cooperation in an interdisciplinary team that combines robotics, AI, medicine and engineering
Completed (medical) technical or scientific studies Ideally, you started your professional path in software development and then you developed further in the areas of quality management and regulatory affairs for interest and conviction. Safe handling of relevant standards, guidelines and regulatory requirements (e.g. MDR, FDA, ISO 13485, IEC 60601 ff.) Experience with international registration and approval processes – ideally in EU and USA Structured and independent working and the ability to set priorities in a dynamic environment Innovation spirit and vision for modern and lean implementations Communication strength, team spirit and a sovereign appearance German and English language skills in word and writing readiness for occasional missions (e.g. for audits, partner meetings, government contacts) Joy in taking responsibility and actively shaping in a high-tech start-up
An agile, interdisciplinary team that combines top research, clinical practice and high-tech development Design space: You build structures – not only processes, but also standards for future innovation projects Direct Impact: Your work helps robotic systems to be safely used in surgery and interventions Flexible working hours Flat hierarchies, quick decisions and an environment that lets you grow Promoting your personal and professional development Aid for occupational pension provision JobRad for environmentally friendly mobility Modern technical equipment 30 days off A team that inspires, supports each other – and wants to write together medical history
Location
 | BEC Medical GmbH | |
| 39106 Magdeburg | ||
| Germany |
The text of this ad was translated from German into English using an automatic translation system and may contain semantic and lexical errors. Therefore, it should be used for introductory purposes only. For more detailed information, see the original text of the ad at the link below.
For more information read the original ad