Regulatory Affairs Manager, Medtech

☞ CTC Resourcing Solutions

Ver: 167

Dia de atualização: 26-03-2024

Localização: Zürich Zürich ZH

Categoria: Farmacêutico / Químico / Biotecnologia

Indústria:

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Conteúdo do emprego

For our medical device clients in Switzerland we are constantly looking to connect with experienced professionals in several areas, including pre-clinical development, clinical research, medical affairs, regulatory affairs, etc.

One of the roles we often recruit for is a Regulatory Affairs Manager. The major goal is for activities associated with regulatory approval of medical device or in vitro diagnostic medical devices including the overall development, implementation and coordination of regulatory strategies and activities with a focus on hardware and software products and projects.

Main Responsibilities

  • Provide regulatory support to the R&D Project teams with the applicable Design Control processes;
  • Provide team members ad hoc specific education;
  • Provide qualification and classification of the development object and related submission strategy;
  • Interface with the correspondent RA-FL for submission strategies, planning and support;
  • Escalate project related regulatory issues;
  • Review labelling;
  • Assemble the documents and the project deliverable (or coordinate the activities) for the preparation of worldwide registration and resolution of possible conflicts;
  • Administrate Product declarations, Certificates and other, similar documents;
  • 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 relevant changes, issues during product development and life cycle management;
  • Accomplish of conformity evaluation including compilation of the conformity declaration for new and existing products;
  • Define and provide Training on Regulatory submission topics;
  • Monitor regulatory requirements, including communication and distribution in a level appropriate manner;
  • Implement divisional and local-strategies.

Qualification, Experience and Key Competencies

  • RelevantSwissworking/residencypermitorSwiss/EU-Citizenship required;
  • Minimum 5 years in hands regulatory affairs in in vitro diagnostic/medical devices;
  • Experience in global regulatory affairs working on development projects in medical devices (MD or IVD)
  • Experience in Medtech industry;
  • Experience with hard and soft wares (working with instruments);
  • Scientific degree (microbiology or chemistry) or an engineering degree;
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Data limite: 10-05-2024

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