Overview
About Bruker Corporation – Leader of the Post-Genomic Era
Bruker is enabling scientists and engineers to make breakthrough post-genomic discoveries and develop new applications that improve the quality of human life. Bruker’s high performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity, and customer success in post-genomic life science molecular and cell biology research, in applied and biopharma applications, in microscopy and nanoanalysis, as well as in industrial and cleantech research, and next-gen semiconductor metrology in support of AI. Bruker offers differentiated, high-value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single-cell biology, functional structural and condensate biology, as well as in clinical microbiology and molecular diagnostics.
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For our Division in Ettlingen we are searching for Regulatory Affairs Specialist (m/f/d)
This is a limited 2 years contract for a maternity leave replacement.
Responsibilities
1. RA support during the whole product life cycle (development, certification / registration/ marketing material/post market surveillance)
2. Establish and update processes in your area of responsibility for staying in compliance in a changing regulatory environment, including environmental regulations (Reach, RoHS…)
3. Lead/support communication (registration/reporting) with authorities/regulatory agencies/designated bodies (EU and worldwide) and manage international audit/inspection programs as required.
4. Coordinate, manage and implement regulatory strategies for new and established products
5. Lead/support efforts to register and launch new products.
6. Lead/support post market surveillance activities from a regulatory perspective.
7. Lead/support CAPA activities from a regulatory perspective.
8. Supporting NRTL certification, Factory Inspection
Does this sound interesting to you?
Qualifications
9. Diplom/ Master's degree in Engineering (electrical / mechanical)
10. Fluent in English and German (min. C1- Level)
11. Optional: Advanced training, additional qualifications:Risk Management (EN ISO 1471)Software Life Cycle processes
Basic Experience with IEC/EN 62304 and IEC/EN 62366
Knowledge of EMC, electrical safety standards (IEC/EN 61010 IEC/EN 60601)
12. Minimum 3-5 years practical experience in Regulatory Affairs or connected field (. Quality), preferred analytical
instrumentation, electrical, electronical industry
13. Ability to manage conflict situations
14. Able to work autonomously
15. Organizational skills
16. Solution-oriented work and Team-Player
Then get started today – we are keen getting to know you!