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
We offer
- Excellent conditions for innovative, vital- and implementation-oriented research in the context of SCI epidemiology
- A position in a stimulating and productive working atmosphere
The position is available as of May 1st, 2026 (or upon agreement) for a period of 3 years with the possibility of an extension.
For this position we require complete application documents (including a cover letter, CV, employment references and educational certificates). Thank you!
What you can expect
Your work is meaningful – you support a globally unique network of services for people with a spinal cord injury.
Your work is meaningful – you support a globally unique network of services for people with a spinal cord injury.
We're all on first name terms and on an equal footing. The close interaction, our staff parties and team events ensure a homely atmosphere.
We're all on first name terms and on an equal footing. The close interaction, our staff parties and team events ensure a homely atmosphere.
Numerous rest areas and sports options offer the chance to relax and unwind. You can choose: fitness, indoor swimming pool, private beach, rose garden or rather team sports?
Numerous rest areas and sports options offer the chance to relax and unwind. You can choose: fitness, indoor swimming pool, private beach, rose garden or rather team sports?
We are a “research institute of national importance” recognized and funded by the Swiss federal and cantonal governments.
We are a “research institute of national importance” recognized and funded by the Swiss federal and cantonal governments.
You enjoy five to seven weeks' holiday and up to 16 paid public holidays per year. Other options are holiday purchase, unpaid leave or a sabbatical after 10 years of service.
You enjoy five to seven weeks' holiday and up to 16 paid public holidays per year. Other options are holiday purchase, unpaid leave or a sabbatical after 10 years of service.
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.
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