Regulatory Affairs Specialist
vor 3 Wochen
Überblick
Bruker is enabling scientists to make breakthrough 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 life science molecular and cell biology research, in applied and pharma applications, in microscopy and nanoanalysis, as well as in industrial applications. 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. Today, worldwide more than 8500 employees are working on this permanent challenge at over 90 locations.
Bruker continues to build upon its extensive range of products and solutions, its broad base of installed systems and a strong reputation among its customers. Being one of the world's leading analytical instrumentation companies, Bruker is strongly committed to further fully meet its customers’ needs as well as to continue to develop state-of-the-art technologies and innovative solutions for today's analytical questions.
Please visit .
We are looking for an Regulatory Affairs Specialist / Manager (m/w/d) for our Bruker entity located in Ettlingen.
To this end, we offer you:
A canteen with meal vouchers Job bike Hybrid working possibilities Support for your pension scheme Capital-forming benefits 30 days of vacation Modern air-conditioned buildings State-of-the-art office space & infrastructure Free employee parking Highly satisfied and forward striving teams Talented and diverse employees from and all over the world Finally, of course, the fact that even though we are listed on the stock exchange, we are still safe and sound in the hands of our owner and thus able to weather all storms.
Aufgaben/Verantwortlichkeiten
RA support during the whole product life cycle (development, certification / registration/ marketing material/post market surveillance)
Establish and update processes in your area of responsibility for staying in compliance in a changing regulatory environment, including environmental regulations (Reach, RoHS…)
Lead/support communication (registration/reporting) with authorities/regulatory agencies/designated bodies (EU and worldwide) and manage international audit/inspection programs as required
Coordinate, manage and implement regulatory strategies for new and established products
Lead/support efforts to register and launch new products
Lead/support post market surveillance activities from a regulatory perspective
Lead/support CAPA activities from a regulatory perspective
Mentor/coach/advise on IVD/MD related processes within the organization
Supporting NRTL certification, Factory Inspection
Does this sound interesting to you?
Qualifikationen
Diplom/ Master's degree in medical technologies, engineering, natural sciences
Optional: Advanced training, additional qualifications
Market Surveillance (PMS & Vigilance) Usability and Software Life Cycle processes conformity assessment of IVD/MD products, registrations in key markets (CE, US, China)Minimum 5 years of experience in Quality and/or Regulatory Affairs for medical products or related areas with comprehensive knowledge of regulations for IVDs, (instruments, software, reagents), focus: CE-countries, US
Knowledge in Post-Market-Surveillance Activities of IVD / medical devices
Knowledge of ISO 14971 Risk Assessment Activities and Risk Management of medical devices
Basic Experience with IEC/EN 62304 and IEC/EN 62366
Basic Knowledge of IEC/EN 61010 (preferred) or IEC/EN 6060
Fluent in English and GermanThen get started today – we are keen getting to know you
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