Consultant MedTech Compliance

Compliance Services - Schweiz - Basel, Zürich, Frankfurt - Rhein Main area

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About Arcondis

Wir schaffen Mehrwert durch funktionsübergreifende, ausgefeilte Projektabwicklung und intelligente Implementierung.

Unsere Kunden lieben die Zusammenarbeit mit uns aufgrund unserer einzigartigen Fähigkeiten, unseres pragmatischen Ansatzes und unseres unbedingten Erfolgswillens. We make healthcare better.

Open Position

Tasks and responsibilities

  • Identification, independent analysis and assessment of compliance-related topics in the MedTech industry
  • Development and implementation of compliance solutions
  • Planing and performing audits
  • Project and stakeholder management
  • Communication and client contact

Your profile

  • Academic education in the field of science, business informatics or business engineering
  • At least 3 years experience in MedTech industry (including in-vitro diagnostic) with a focus on quality, regulatory affairs, manufacturing, R&D or IT
  • Project management experience with focus on quality assurance & compliance with further interfaces to IT-related topics (e.g. security, cloud, data management, data integrity, data privacy)
  • Theoretical and applied knowledge of standards, norms and regulations (e.g. ISO 13485, ISO 14971, IEC 62366, IEC 82304, IEC 62304)
  • Theoretical and applied knowledge about MDR, IVDR and additional international regulations
  • Methodical approach and good analytical skills
  • Teamplayer
  • Very good verbal and written communication skills in English and German
  • Passion to continuously develop and grow with new challenges

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