Astek is looking for a Product Risk Manager to work with our leading pharmaceutical partner in an international environment.
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Who are you?
* A degree in Biomedical Engineering, Computer Science, Computer Engineering, or related field
* 5+ years of experience in the software industry.
* At least 3 years of hands-on risk management experience in medical devices and technical documentation.
* Strong knowledge of regulations and standards (ISO 13485, MDR/IVDR, FDA, 21 CFR 820, ISO QMS).
* Experience with cybersecurity and data privacy frameworks (ISO 27001, HITRUST, GDPR).
* Excellent communication skills and experience with Agile methodologies (SAFe, Scrum).
Who are we?
Since 2015, Astek Iberia has been accompanying its customers in their development throughout Spain (Madrid, Barcelona, Valencia, Basque Country, Andalusia, Galicia, etc.).
Founded in France in 1988, Astek is a global player in engineering and technology consulting, present in five continents and 25 countries. With expertise in a wide range of industrial and service sectors, Astek is an essential partner, supporting its customers in an intelligent deployment of their products and services, and in the implementation of their digital transformation.
Today we are more than 8,000 employees, committed every day to promote the complementarity between digital technologies and complex systems engineering. xohynlm
Our style is to have flexible schedules and highly value the well-being of our employees.
Why join us?