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Quality and Regulatory Affairs Specialist (m/w)

Le 9 janvier

Critères de l'offre

  • Zug
  • Permanent contract
  • Full Time
  • Domaines d'expertise : Subject Matter experts , Support , External , Functional programming , Strategic Voir plus , Coordinates , FDA , Regulation , EMEA , Supervision , Parts , Monitoring , Diabetes , software , Oral communication , Leader Voir moins

L'entreprise : Michael Page

Our client is a world leader in blood monitoring systems. Globally > 20 million people depend on our client devices for testing and helping them manage their diabetes.

Description du poste

  • Oversees the Legal Manufacturer office for our clients device portfolio.
  • Serves as point of contact host for Notified Bodies and Competent Authority audits (incl. FDA).
  • Serves as Quality and Regulatory Management Representative for Swiss site.
  • Approves Power of Attorney to authorise third party distributors.
  • Approves documents on behalf of Legal Manufacturer in support of global regulatory licenses, in close partnership with Global Regulatory team.
  • Provides local regulatory support, where required, to the EMEA region .
  • Monitors emerging EU regulatory requirements related to product portfolio, interprets and communicates to Global Regulatory team.
  • Where appropriate, influences the EU external regulatory environment by participating in regulatory policy reviews.
  • Coordinates feedback from company subject matter experts and submits comments on behalf of our client to the various EU bodies developing regulations.
  • Register products with Swissmedic in accordance with local requirements.

Description du profil

Personal Skills
  • Ability to work with little supervision.
  • Ability to work collaboratively as part of cross-functional teams.
  • Intellectually curious, interest in shaping future regulatory requirements.
  • Ability to understand complex situations and develop strategic plans to meet business needs.
  • Excellent written and verbal communication.
  • Ability to think creatively and provide solutions.
Essential Technical Skills
  • Regulatory Affairs / Quality Assurance experience within the medical device industry.
  • Experience within the notification of Medical Devices to Swissmedic.
  • Knowledge of New EU Medical Devices regulations.
  • Experience in monitoring and interpreting business impact of changing regulatory requirements.
  • A degree/equivalent in a scientific discipline.
Preferred Technical Skills
  • Experience participating in industry groups, reviewing and commenting on draft regulatory policy.
  • Knowledge of Software as a Medical Device
  • Experience within the notification of IVDs and Medical Devices to Swissmedic

Référence : 101644_MP_CH

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