Regulatory Affairs & Quality Assurance Manager

These are your tasks

• Provide high quality regulatory affairs-related services for investigators in the field of patient-oriented research with a risk-based approach (e.g. review of study protocols and other essential study documents)
• Promote the implementation of the ICH Good Clinical Practice (ICH-GCP) guidelines
• Be subject matter expert for regulatory affairs related topics in the context of clinical trials and research projects
• Be responsible for the quality management system of the CTU, i.e. development, implementation and maintenance of study related processes, incl. SOPs, forms and other related documents
• Support clinical researchers with the registration of studies in official national and international registries
• Submit study documents for selected studies' approval by ethics committees
• Support study teams in the context of audits and inspections by ethics committees or regulatory authorities
• Teach on national and international clinical research regulations (e.g. Human Research Act (HFG); ICH-GCP guidelines)

What makes you stand out

• Master in health or natural sciences; PhD would be an advantage
• Excellent knowledge of and experience in working with national and international clinical research regulations (e.g. HFG, ICH-GCP)
• Profound knowledge and experience of processes in patient-oriented research; including trials with medical devices and medicinal products
• Experience with audits and inspections by ethics committees or regulatory authorities is an advantage
• Good knowledge of rehabilitation medicine and spinal cord injury/disease is an advantage
• Excellent German (business fluent) and good English language skills; both spoken and written
• Self-managed way of working, strong customer orientation, able to work in a team, excellent communication skills

What you can expect

You can expect attractive employment conditions as well as numerous other advantages. Look forward to meaningful work in a modern work environment, flexible working times and various further training opportunities. Come and join us and experience our unique spirit. More information at parplegie.ch/vorteile.

About us

Swiss Paraplegic Research (SPF) is part of the Swiss Paraplegic Group. The mission of SPF is sustainably improving the situation of people with spinal cord injury (SCI) through interdisciplinary, clinical and Community-based research on a national and international level. Specific areas of its comprehensive research include functioning, mobility, social integration, equality of opportunity, self-determination, quality of life, health services provision as well as epidemiology and statistical methods. SPF is an university research institution recognized and promoted by the Swiss federal government and the cantons and an active link to academic and industrial research and development at the national and international levels.

Your contact person

Questions about the application process

Lea Blunschi

HR Manager

041 939 53 72

Questions on the job

Christine Thyrian

Head CTU

+41 41 939 65 94