Clinical Research & Evaluation Manager

Ypsomed AG; Burgdorf; Hybrid; CHF 85’000 - 120’000; Vollzeit

Zusammenfassung

A leading company in medical technology seeks a Clinical Research & Evaluation Manager to oversee clinical evaluations and PMCF of medical devices. The role involves collaboration with diverse teams, regulatory compliance, and contributing to scientific publications and conferences. Candidates should possess a Master's degree and have experience in the medical device industry.

Qualifikationen

• Master’s degree in natural or health science discipline required.
• 2+ years experience in Clinical Evaluation and PMCF for medical devices.
• Fluent in English, both written and spoken.

Aufgaben

• Preparation and maintenance of Clinical Evaluations and PMCF.
• Coordination of interdisciplinary studies and collaboration with external partners.
• Publishing study results in scientific journals and presenting at conferences.

Kenntnisse

Regulatory Compliance

Clinical Evaluation

Scientific Writing

Project Management

Ausbildung

Master’s degree in natural or health science

PhD or MD

Jobbeschreibung

As a Clinical Research & Evaluation Manager, you will play a key role in our Medical Affairs team within the Science & Evidence department. You will be responsible for clinical evaluations and Post-Market Clinical Follow-up (PMCF) of our medical devices throughout their lifecycle. Collaborating closely with internal teams-R&D, Marketing, and Regulatory Affairs-as well as with external partners such as pharmaceutical companies, suppliers, and notified bodies, you will contribute to both regulatory compliance and scientific leadership. Your work will strengthen product claims through robust evidence and elevate our scientific visibility via publications and conference contributions. If you're passionate about clinical science, evidence-based innovation, and interdisciplinary collaboration in a high-impact environment, we look forward to welcoming you to our team. In the area of Quality Management, Regulatory & Medical Affairs we are looking for a motivated person at the Burgdorf site as

Clinical Research & Evaluation Manager | 80 - 100%

Ref. No. 7711

Location:Burgdorf|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

• Independent preparation and maintenance of Clinical Evaluations as well as execution of Post-Market Clinical Follow-up (PMCF) within product development and product maintenance projects in accordance with the Medical Device Regulation (MDR)
• Coordination of interdisciplinary studies in collaboration with external pharmaceutical companies, suppliers, or at the interface with Human Factors Engineering, and in close cooperation with R&D, Marketing, and Regulatory Affairs
• Publishing study results in scientific journals, whitepapers, or presenting at conferences
• Analysis and publication of existing data sets
• Integration of modern technologies, such as the use of Artificial Intelligence (AI) for the creation, maintenance and review of clinical documentation
• Proactive maintenance of regulatory requirements. Development and documentation of internal processes and defense of internal documentation in Audits
• Interpretation of relevant standards, conducting gap analyses and ensuring compliance within the area of responsibility

Your profile

• Completed Master’s degree (MSc) in a natural or health science discipline or an equivalent qualification
• PhD or MD or a strong scientific background and publication experience is an advantage
• At least two years of experience in the field of Clinical Evaluation and PMCF for medical devices
• Excellent knowledge of regulatory standards: MDR (2017/745), MEDDEV 2.7.1 Rev. 4, Good Clinical Practice ISO 14155, and hands-on experience in the medical device industry – ideally with Class IIa or IIb products
• Strong scientific understanding and solid experience in scientific writing and publishing are a plus
• Experience in clinical science, risk analysis and clinical study planning in the medtech industry is a plus
• High level of organizational skills, strong communication abilities, inspiring team spirit, persuasiveness, and enthusiasm for interdisciplinary collaboration
• Interest in – and ideally experience with – AI technologies, e.g. to support clinical evaluations
• Fluent in English, both written and spoken

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

Alain Rusconi
Human Resources Expert Recruiting

[phone]

Your future place of work

Burgdorf