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Regulatory Affairs Manager

Regulatory Affairs Manager

Chemie / Pharma / Biotechnologie
  • Temporär - Vollzeit
  • Referenz : INT-032762
  • Teilen:

Einzelheiten

  • Region Zug
  • Art des Vertrags Temporär - Vollzeit
  • Tätigkeitssektor Chemie / Pharma / Biotechnologie

Einführung

As a preferred supplier for Roche Diagnostics Int Ltd in Rotkreuz, we are looking for an individual as

Regulatory Affairs Manager

(contract for 1 year duration, with possible extension). The earliest start date is asap or within 2 months. Onsite/Homeoffice: After onboarding, once per week onsite.

Aufgabenbeschreibung

  • Provides regulatory support to the R&D Project teams with the applicable Design Control processes
  • Provides team members ad hoc specific education;
  • Provides qualification and classification of the development object and related submission strategy;
  • Escalates project related regulatory issues;
  • Review of labelling
  • Assemble the documents and the project deliverable (or coordinate the activities) for the preparation of world-wide registration and resolution of possible conflicts.
  • Administration of Product declarations, Certificates and other, similar documents
  • Interaction with other regulatory functions: Define and implement necessary processes, strategies and SOPs to manage the interfaces within the assigned area; ensure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest.
  • Interaction with functions other than regulatory functions: education of staff members of R&D and Portfolio Management on regulatory related topics (e.g. regulations or changes in the regulations); provide support for specific topic/questions


Erforderliches Profil

  • At least 5 years of experience as a Regulatory Affairs Manager in IVD Instruments
  • At least 5 years of experience with Development of IVD Devices
  • Regulatory Affairs experience with software development
  • Experience with risk management
  • Very good command of English is required
  • Bachelor or Master Degree in Life Sciences or Engineering


Nice to haves:

  • German
  • Experience with electrical medical devices
  • Hardware and Software of IVD Instruments as a plus


Application process

Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application. Please upload your CV in English or German along with your degree certificate and latest reference letter.

Informationen

  • Agentur GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
  • Veröffentlicht am 17. August 2022
  • Berater-in Jie Zhu