QM & Regulatory Specialist (m/w/d)

• Establish and further develop the QM system: You will develop our quality management system in accordance with ISO 13485 - from initial documentation to continuous improvement. Optionally, you can also incorporate aspects such as ISO 27001.

• Regulatory strategy & documentation: You develop a clear regulatory strategy for our products, keep an eye on legislative changes and maintain up-to-date and comprehensible regulatory documentation.

• Interface & sparring partner: You work closely with the development team and management and coordinate with external stakeholders - including authorities, notified bodies and partners.

• Ensure quality: You establish processes for risk management, audits, complaints and continuous improvement. You will carry out internal audits independently or in collaboration.

• AI & Compliance: You will work with us to develop the foundations for the secure and compliant use of our AI - including classification, technical documentation and monitoring in accordance with the EU AI Act.

• Audits & inspections: You accompany external audits and inspections and ensure that we are able to provide information and are compliant at all times.

• You want to work part-time, but want to be fully involved in thinking, shaping and taking responsibility.

• You work in a structured, efficient and self-organised manner - and enjoy presenting complex topics in an understandable way and putting them into practice.

• You communicate clearly and at eye level, can win others over to your topics and enjoy working with different teams.

• You have gained experience in quality management or in a regulatory environment - whether through professional stations, projects or further training is less important to us than your expertise and motivation.

• A degree or training in a technical, scientific, medical or business field is a plus - but not a mandatory requirement.

• You are already familiar with ISO 13485, ISO 14971 or the EU AI Act - or you are keen to familiarise yourself quickly and thoroughly with these topics.

• You have a good understanding of processes, documentation and regulatory requirements - ideally complemented by initial experience in risk management, document control or audit preparation.

• A very good level of German will help you with documentation and internal communication, and you will need English skills for standards and technical literature.

• A meaningful role with strategic importance: you are the first person with primary responsibility for shaping quality management and regulatory work at our company - with a direct link to the management and close dialogue with our development team.

• Creative freedom and trust: You work independently, contribute your ideas and help shape structures, processes and standards - at eye level and with support.

• Flexible part-time work: We offer you a role with real flexibility - in terms of working hours and organisation. Two attendance days per week in our office, the rest is flexible and mobile.

• Further development highly desired: We support you with further and advanced training - whether in ISO standards, regulatory affairs or AI regulation.

• An environment with attitude: We are a team of around 20 people - mainly developers - who work on innovative, medically relevant products with a great deal of professional depth and teamwork.

• Short decision-making processes, real collaboration: We don't have long official channels, but flat hierarchies and a genuine interest in your input.

• Part-time, but not ‘part-responsibility’: Your role is crucial for the quality and approval of our products - you make the difference.

You don't fulfil every single requirement, but you feel it appeals to you and have relevant experience? Then feel free to apply - we know that CVs are as diverse as we humans are. A LinkedIn profile or a short CV is all we need to get started.

We look forward to hearing from you!