Clinical and regulatory research specialist - NeuroRestore laboratory
The NeuroRestore laboratory at CHUV (Lausanne University Hospital) is offering a position for a Clinical and Regulatory Research Specialist for an occupational rate of 80% - 100%.
The Lausanne University Hospital CHUV is one in five university hospitals in Switzerland, and the only one in the French‑speaking part of the country carrying out DBS implantations for Parkinsonian conditions, with more than 50 cases per year. Academically, it is linked to the Faculty of Biology and Medicine of the University of Lausanne (UNIL) and it holds close ties to the Swiss Federal Institute of Technology in Lausanne (EPFL).
NeuroRestore is a research and innovation centre spanning EPFL and CHUV that develops bioengineering strategies involving neurosurgical interventions to restore neurological functions. Our innovative treatments result from rigorous preclinical studies that have been conducted during the last 15 years in rodent and non‑human primate models.
At CHUV, we perform early feasibility clinical trials (C2) with implantable neurotechnologies (Class III medical device) to restore neurological functions in people with Spinal Cord Injury, Parkinson’s Disease, or Stroke.
Mission
CHUV is seeking a Clinical and Regulatory Research Specialist to lead the preparation of regulatory submissions and support the clinical team in the management of clinical trials. The specialist will contribute to several studies in parallel and be involved in all phases of a clinical trial, from study start‑up through to study completion.
Prepare clinical documentation for submission to the ethics committee and the competent authority:
* Write clinical trial amendments and documentation for submission to Swissmedic and CER‑VD.
* Support writing and review of medical device technical files, such as risk management activities, requirements, testing plan and reports.
Support the conduct of ongoing clinical trials:
* Ensure trials are conducted according to the protocol.
* Perform Trial Master Files & Investigator Site Files completeness checks.
* Perform data completeness checks prior monitoring visit.
Profil
* Master degree in biomedical engineering or similar.
* Minimum 2 years of experience in clinical operations/ regulatory field.
* Excellent rigor and attention to detail.
* Solid understanding of clinical trial processes, GCP, and regulatory requirements.
* Fluency in English.
* Ability to work independently along with a multidisciplinary team on a large portfolio of clinical trials.
Nice to have:
* Prior experience in medical devices clinical trials strongly preferred.
* Experience with medical device risk management processes (ISO 14971).
* Interest in neuromodulation therapies.
Nous offrons
To become an employee of the world‑famous University Hospital Centre from the Canton of Vaud is an assurance of:
* First‑rate social benefits such as a Paternity Leave of 20 days and a Maternity Leave of 4 months (there is also the possibility to obtain a complementary breastfeeding leave of 1 month)
* Regular salary progression adapted to your responsibilities
* A 13th salary and 25 days of vacation per year
* A right to at least three days of training per year, by accessing a wide offer of courses not only from the CHUV Training Centre but also from external providers
* Possibility to access one of the 500 furnished apartments offered in the surrounding neighbourhoods in case of relocation in Switzerland
* Discounts proposed on social and cultural events, goodies and other services, thanks to the “H‑Oxygène” association
* Signing up to our Mobility Plan and benefit from different advantages (discounts on public transportation, promotion of a “Mobility” car fleet and discounts on electric bikes)
* Being able to enjoy our high‑quality corporate restaurants, located in every hospital building, with employees’ discount
The CHUV applies the highest quality requirements as part of its recruitment process. In addition, mindful to promote workplace diversity and inclusion, we strive to ensure equal treatment and avoid any discrimination. We are looking forward to receiving your application.
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