QA / RA in Medical Technology
ALTRAN
Basel
vor 2 Tg.

Avec plus de 45'000 consultants dans le monde et générant un chiffre d’affaires d'EUR. 2.9 Mia, le Groupe Altran est le leader mondial dans les services d’ingénierie et de R&D (ER&D).

En Suisse, Altran emploie plus de 250 consultants et vise une forte croissance avec des bureaux à Zurich, Bâle, Lausanne et Genève.

Altran déploie son expertise notamment dans les secteurs suivants :

  • Sciences de la vie (Pharma, Biotech, et Dispositifs médicaux),
  • Industrie, Aéronautique, Automobile, Energie, Transports Ferroviaire,
  • Services financiers : Assurance des personnes et des biens, Assurance maladie, Réassurance, Banque
  • Secteur public
  • Titre du poste QA / RA in Medical Technology
  • Numéro de référence 14949
  • Lieu de travail Suisse / CHE - Toutes régions /
  • Zürich
  • Type de contrat CDI Temps plein
  • Nombre minimum d’années d’expérience requis 5 ans d'expérience et plus
  • Notre offre

  • A permanent contract with the leader in innovation and high-tech engineering consulting
  • A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR.
  • 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).

  • In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
  • Altran deploys its expertise particularly in : Life Sciences (Pharma, Biotech, and Medical Devices), Industry, Aerospace, Automotive, Energy, Railways
  • Vos responsabilités

  • Review and provide regulatory impact assessments for changes
  • Represent and reinforce Quality Assurance and Regulatory Affairs requirements
  • Work in a multidisciplinary group for Technical File adaption according to MDR 2017 / 745
  • Change assessment, variation planning
  • Execute global plans and regulatory submission deliverables for sustaining variations
  • Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results
  • Create and maintain Technical Files / Design Dossiers
  • Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements
  • 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
  • Votre profil

  • MSc / PhD degree in Pharmacy, Regulatory field
  • Minimum 5 years 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
  • Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines
  • Exercise independent judgement
  • Scientific knowledge and ability to discuss technical matters with cross-functional team members
  • Ability to identify compliance risks and escalate when necessary
  • Experience in Audits would be a plus
  • Languages : English fluent, German is a plus
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