Veröffentlicht:05 Mai 2023
Arbeitsort:Hochbergerstrasse 60E, 4057 Basel
For our Regulatory Affairs Team based at the Medartis Headquarters in Basel, we are looking for a passionate and self-driven
Develop and maintain the Medartis risk management system in accordance with the applicable regulations and standards, in particular ISO 14971:
Content maintenance and further development of the product risk management (dFMEA) of all products as part of the technical files
Perform process risk management (pFMEA), while coordinating with internal and external customers
Ensure the conformity of the risk management across all involved areas and support the creation and continuous update of FMEAs
Design and produce the necessary reports and analyses related to risk management
Dissemination of risk management know-how: further development, maintenance and training of the related business process, instructions, templates
Represent Risk Management in internal and external audits
Advanced technical education, technical degree or comparable applicable degree
Track record as risk manager, development, process or quality engineer
Practical experience with risk management files, process and design FMEAs
Fluency in English, good level of German
Experience in the application of statistical methods
Experience in quality management of a medical device manufacturer (MDR, ISO 13485:2016) or pharmaceutical company
Knowledgeable about technical files and their interrelationships in terms of content, as well as product development processes
Medartis is a leading medical device manufacturer specializing in high-precision implants for the surgical fixation of bone fractures, fusions, and osteotomies. Our motto of "Precision in Fixation" is our commitment to innovative development and stringent quality standards with the goal of improving the patient's quality of life.
This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company. We look forward to receiving your complete application.
For further information please visit our Website www.medartis.com.
We look forward to receiving your complete online application.
T +41 61 633 34 34