In the area of Quality Management, Regulatory and Medical Affairs in Solothurn, we are looking for an experienced and passionate person to join the Medical Affairs team as a

Clinical Research & Evaluation Manager | 80%

Ref. No. 6953

Location: Solothurn | Hybrid

Help us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.

Your main tasks

[Responsible for overseeing global clinical trials, ensuring compliance with ISO 14155:2020, the Declaration of Helsinki, and relevant national laws and regulations. This includes adherence to Articles 62 through 82 and Annex XV of EU Regulation 2017/745 (MDR), as well as adhering to U.S. clinical trial standards as governed by the Food and Drug Administration (FDA), Responsibility for adherence to budgets, timelines, milestones, and task completion of clinical trials, Supervising and supporting CROs and trial centers in the preparation and conduct of clinical studies in compliance in close collaboration with medical experts and external advisors, Planning, coordination and conduct of audits according to predefined audit plans and checklists at CROs and trial sites to ensure compliance with GCP guidelines, internal quality standards, study protocols and regulatory requirements, Establish and maintain a constructive relationship with local & international opinion leaders, trial centers, CROs and other third parties, Effective communication with internal and external stakeholders including regulatory authorities, ethics committees, CROs, investigators and advisors, Contribution to the scientific evaluation and interpretation of the study results, including the preparation of reports and publications, Organization and implementation of training measures for Ypsomed employees and study team members to ensure compliance with study standards and guidelines, Medical-scientific support for the internal R&D, Marketing & Sales etc. departments, Writing of Clinical Development Plans / Clinical Evaluation Plans and Reports, Post Market Clinical Follow Up Plans (and Reports) for new products and new indications]

Your profile

[Master of Science (MSc) degree in a natural science discipline or in the health sector, or equivalent qualification, Doctorate (PhD or Dr.) is an advantage, > 2 years of experience in planning and monitoring clinical trials, Very good knowledge of the standard requirements ISO 14155-GCP and 2017/745 for Medical Devices (MDR), as well as applicable FDA regulations, Sound knowledge of clinical research/testing methodology, Knowledge of the medical device industry and strong scientific understanding (experience in the field of medical devices, at least class II) , Fluent in written and spoken English , Any other language is an advantage]

Ypsomed - making the treatment of chronic diseases possible

More than 2,000 employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treatment. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life.

Contact

Claudia Menges
Manager Recruiting

+41 34 424 28 82

Your future place of work

Solothurn

Solothurn