Consultant MedTech Compliance

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

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About Arcondis

ARCONDIS is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,


information technology, and digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

Open Position
Mission

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
Studies

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
Contact

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