Regulatory Affairs Specialist - Clinical Diagnostics | Chemielaborant / CTA / Chemikant / Chemie-BAC Regulatory Affairs - Klinische Diagnostik (m/w/d)
Chromsystems GmbH
Job Summary
This role involves supporting the Regulatory Affairs team at Chromsystems, a leader in clinical diagnostics. You will be responsible for executing product stability programs, conducting independent investigations according to test plans, and evaluating resulting data. A significant portion of the day-to-day work involves measuring proficiency tests (Ringversuche) as part of quality assurance and market surveillance. You will also assist in international product registration efforts by documenting raw data and writing test reports based on current standards and specifications. The position is ideal for someone who enjoys hands-on laboratory work with analytical instruments like HPLC and LC-MS/MS while maintaining high standards for documentation and organizational excellence. This is an attractive opportunity to join a stable, growing company in Gräfelfing (near Munich) that offers a modern working environment, flexible hours, and no shift work, all while contributing to medical progress through innovative diagnostic products.
Required Skills
Education
Completed vocational training as a Chemical Technical Assistant (CTA), Chemical Laboratory Technician, or a Bachelor's degree in Chemistry.
Experience
- Professional experience in a clinical-chemical laboratory or the pharmaceutical industry
- Practical experience in the application of HPLC and/or LC-MS/MS
- Experience in evaluating raw data and writing technical test reports
- Experience in maintaining and operating analytical laboratory equipment
Languages
Additional
- Location: Gräfelfing near Munich. Full-time, permanent position. Requires the ability to perform organizational laboratory tasks and maintain compliance with valid specifications and standards.
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