Bracco Injeenering SA is a company of the international Bracco Group (www.bracco.com).
Bracco Group : Bracco is an international Group active in the healthcare sector through Bracco Imaging (diagnostic imaging), ACIST Medical Systems (medical devices and advanced imaging agents injection systems), and the Centro Diagnostico Italiano diagnostic clinic in Milan. It has more than 3,450 employees and annual total consolidated revenues of around 1.3 billion euros, of which 87% from international sales, and it is present worldwide. In the Research and Development area, the company invests approximately 9% of reference turnover in the imaging diagnostics and medical devices sectors and has a portfolio comprising over 1,800 patents. Its subsidiary Bracco Imaging is one of the world’s leading companies in the diagnostic imaging field :X-Ray Imaging (including Computed Tomography-CT), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound, and Nuclear Medicine. The Company operates in over 90 markets: in North America through Bracco Diagnostics Inc. USA headquartered in Princeton, NJ, and with an affiliate in Montreal (Canada); in Europe, with offices in all major countries; in Japan (BRACCO-EISAI). The Company also operates in South America, South Korea and China through its 70% controlled Joint Venture, Bracco Sine Pharmaceutical Corp. Ltd
Bracco Injeneering: In July 2011, the Bracco Group acquired Swiss Medical Care to strengthen and complete the portfolio of automated system for the administration of contrast media with technological advancements such as CT Exprès.
Effective December 17, 2012, SMC has changed its name to BRACCO INJENEERING S.A., the new Business Unit of Bracco Imaging SpA.
The name BRACCO INJENEERING denotes a company committed to developing the best-in-class integrated injection solutions with a strong heritage in research and innovation. It provides quality solutions for state-of-the-art radiology centers, offering proven injection technology, built on Bracco Imaging expertise. BRACCO INJENEERING S.A. is based in Lausanne.
Manage Regulatory Affairs activities for informatics program and human factor activities for all new and existing product development, including development of regulatory requirements/strategies. Support BRACCO INJENEERING Regulatory department with international regulators on submission reviews/approvals and ensure compliance with required regulations and established corporate standards. Participate in Regulatory activities associated with product field corrective actions as required and ensure that product approvals are properly maintained and product re-submissions are properly managed. Exercise creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks. The position will be interfacing with regulatory bodies, third party consultants, marketing, R&D team and management, and assist in developing ideas for solutions consistent with our product development roadmap.
Duty & Responsibilities / Percent of Time:
Regulatory Affairs / 60%:
Human Factor / 40%:
Required Skills - Qualifications (Knowledge, Skills & Abilities):
What we offer:
Job Location: Bracco Injeneering - Lausanne - Switzerland
Position Type: Full-time
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