Clinical Evaluation Specialist (m/f/d) 100%
BÜHLMANN Laboratories AG
Schönenbuch
Key information
- Publication date:24 July 2025
- Workload:100%
- Contract type:Permanent position
- Place of work:Schönenbuch
Job summary
Join BÜHLMANN Laboratories AG, a leader in Life Sciences! Exciting opportunity in a supportive work environment awaits.
Tasks
- Create Clinical Performance Reports for IVD products.
- Coordinate clinical performance studies with various teams.
- Assist in international regulatory submissions and research.
Skills
- Master's, MD, or PhD in relevant science field required.
- Experience in clinical studies and FDA submissions.
- Strong English and good German communication skills.
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- Creation of Clinical Evidence Reports (e.g., Clinical Performance Reports, SVA Reports, PERs) according to IVDR 2017/746
- Planning, coordination, and execution of clinical performance evaluation studies in close collaboration with Development, Global Marketing, and external partners
- Writing and submitting applications to ethics committees
- Conducting literature searches and creating corresponding reports
- Summarizing and evaluating existing analytical and clinical study results
- Contributing to the creation and maintenance of technical documentation for IVD products
- Supporting approval processes for international markets
- Researching regulatory requirements and relevant standards
- University degree (MSc, MD, PhD) in natural sciences, medicine, pharmacy, biochemistry, or similar
- Experience with clinical studies and project-related work
- Experience with FDA approval projects for IVD/medical devices
- Good knowledge of GCP, ISO 14155, and regulatory requirements (IVD, MD)
- Very good IT user skills (MS Office)
- Very good English skills, good German skills in spoken and written form
- Precise, methodical, and reliable working style as well as team spirit and personal responsibility
- A central role with high responsibility in a highly specialized environment
- An international, innovative company with flat hierarchies and short decision-making processes
- A dedicated, collegial team that combines professionalism and team spirit
- Diverse training and development opportunities
- Modern infrastructure at the headquarters in Schönenbuch - plus flexible home office option
- Attractive employment conditions and benefits that appreciate your commitment
CH-4124 Schönenbuch
