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Regulatory Affairs Manager

Regulatory Affairs Manager

Chemie / Pharma / Biotechnologie
  • Temporär - Vollzeit
  • Referenz : INT-012515
  • Teilen:

Einzelheiten

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

Einführung

As a preferred supplier for Roche Diagnostics in Rotkreuz near Zug, we are looking for an individual as Regulatory Affairs Manager (contract until the end of 2021, with extension if suitable for all parties) start date within 3 months

Aufgabenbeschreibung

1) Project Lead Regulatory, within the scope of a project for new products or during the product life cycle:
  • 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;
  • Interfaces with the correspondent RA-FL for submission strategies, planning and support;
  • Escalates project related regulatory issues;
  • Review of labelling
  • Assemble the documents and the project deliverable (or coordinate the activities) for the preparation of worldwide registration and resolution of possible conflicts.
  • Administration of Product declarations, Certificates and other, similar documents
2) Global Regulatory Affairs Manager - interaction with other regulatory functions:
  • Ensure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest.
  • Inform Global Regulatory Affairs Business areas about changes
  • Inform Global Regulatory Affairs Business areas about relevant issues during product development and life cycle management
3) Global Regulatory Affairs Manager - 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).
  • Accomplish of conformity evaluation including compilation of the conformity declaration for new and existing products.
  • Provide support for specific topic/questions
4) Global Regulatory Affairs Manager-General Task
  • Define and provide Training on Regulatory submission topics
  • Monitor regulatory requirements, including communication and distribution in a level appropriate manner
  • Implementation of divisional and local-strategies


Erforderliches Profil

Must Haves:
  • Minimum 3/4 years in hands-on global regulatory affairs
  • Experience in global regulatory affairs working on development projects in medical devices (MD or IVD)
  • Experience in industry 
  • Experience with software (working with instruments) 
  • Master degree (microbiology or chemistry) / engineering or programming degree
  • RWD knowledge / understanding
  • Excellent communications and negotiations skills
Nice to haves:
  • Fluency in Spanish

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.



Informationen

  • Agentur GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
  • Veröffentlicht am 29. April 2021
  • Berater-in Marijke van Engelenburg