RA/QA Expert Medtech - New MDR (m/f/d) Life Sciences

Einsatzort: Freiburg

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RA/QA Expert Medtech - New MDR (m/f/d) Life Sciences

Freiburg

Altran has been creating the world of tomorrow with the greatest technological expertise, digital innovation and transformative power for over 38 years: on the road, in the air, on the seas, in rail transport, in energy production, in life science, finance and telecommunications. For our renowned customers in the automotive, aerospace & defence, communication & digital, as well as many other sectors, we are the world market leaders for high-tech engineering and R&D services. A French holding company offering consulting and services at the cutting edge of technological progress that assumes responsibility: from the initial concept, through industrialisation, to the development of new products and services. Altran’s decisive key themes include connectivity, mobility of the future, digitalisation and complex technologies, as well as cross-sector solutions such as Lifecycle Experience and Intelligent Systems. Our high-tech expertise stems from our 50,000 highly qualified employees in over 30 countries. In Germany, Altran Deutschland S.A.S. & Co. KG and Altran Service GmbH, headquartered in Munich, have about 3,200 employees in over 30 locations. Ready for excellence?

Unser Angebot

  • Exciting international and national projects in our high-tech customer environment
  • Specialization opportunities as well as subject-specific further education and training
  • A challenging task with high personal responsibility

Ihre Aufgaben

  • Participate on MDR implementation by representing and reinforcing Quality Assurance and Regulatory Affairs requirements      
  • Work in a multidisciplinary group for Technical File adaption according to MDR 2017/745
  • Ensure that the technical documentation supporting the CE mark complies with MDD 93/42/EEC
  • Create and maintain Technical Files/Design Dossiers
  • Support the International Regulatory Affairs Team in preparation of International Submissions
  • Interaction with authorities, notified bodies and any other approving bodies that will be relevant
  • Assessment of potential risks and the classification of the medical device in accordance with MDD and MDR
  • Support and consultation of the Departments in regard of interpretation of regulatory rules/laws/guidelines

Ihr Profil

  • University Degree (Master/PhD) in Pharmacy
  • At least 5yrs of professional experience in Regulatory Affairs and/or Quality Management
  • Detailed knowledge about the standards and directives for Medical Devices such as ISO 13485, ISO 14971, MDD 93/42/EEC and MDR 2017/745
  • Experience from Audits and advanced knowledge of Data Analysis would be a plus
  • Business fluent in English and German