Head of Quality Management & Regulatory Affairs (80 – 100%)

Head of Quality Management & Regulatory Affairs (80 – 100%)

CISTEC AG is a successful SME and continuously seeks qualified and motivated employees. If you are interested in working for an innovative software and service company in the healthcare sector, please contact us. Due to our growth, we are looking for a Head of Quality Management & Regulatory Affairs for our team.

The Head of Quality Management & Regulatory Affairs is responsible for the regulatory compliance, product safety, and quality of our software medical devices (SaMD) throughout the entire product lifecycle. They ensure that all regulatory and normative requirements as well as internal quality standards are met, thereby creating the foundation for safe, legally compliant, and marketable products. Additionally, they ensure close collaboration between product management, development, operations, and external authorities/partners.

Your responsibilities include

• Overall responsibility for Regulatory Affairs and, depending on experience, also Quality Management in the product area
• Ensuring compliance with regulatory and normative requirements
• Leading certification and approval processes for products in relevant markets
• (currently Switzerland)
• Defining the regulatory strategy

You bring with you

• 5+ successfully launched products under MepV/MDR or have successfully prepared a company for MepV/MDR compliance; solid experience in Regulatory Affairs and Quality Management, ideally at least partially in the context of SaMD
• Completed studies in Life Sciences, Medicine, Pharmacy, Regulatory Affairs, or similar
• Deep understanding of Swiss and European medical device regulations (MepV/MDR), including classification, clinical evaluation, PMS/PMCF, vigilance, and technical documentation
• Experience as PRRC is an advantage
• Technical understanding of software architecture, software lifecycle models, risk class-dependent documentation requirements
• Practical experience with AI is highly desirable
• Strong strategic and analytical skills
• Entrepreneurial thinking, high decision-making ability, and leadership qualities
• Several years of experience in the MedTech, hospital, or health-tech industry
• Proven experience in audits, certifications, and managing regulatory interfaces
• High self-motivation, energy, and resilience, especially in dynamic and regulatory demanding environments
• You speak fluent German and business fluent English; French is an advantage

We offer you a varied, designable activity in an exciting and meaningful environment. Our software product and company are in a rapidly growing market. We work in interdisciplinary, agile teams with flat hierarchies and state-of-the-art development and documentation tools. Part-time work, flexible working hours, and home office are a matter of course for us.

Only direct applications will be considered.

If you have any questions, Kathrin Plüer, Team Leader Quality Management, will be happy to assist you (Email: moc.cetsic@reeulp.nirhtak). Please send your complete application documents by email to moc.cetsic@gnubreweb. Please note that feedback will only be given from January 2026. We look forward to getting to know you.