Regulatory Affairs Manager, 70%

Schweiz, Zug, Rotkreuz

en fr es ru tr it pt zh ja

This Regulatory Affairs Function is responsible for the overall development, implementation and coordination of regulatory strategies and activities. The Rotkreuz department is responsible for requirements related to platforms developed with internal and external partners.

 

Key responsibilities

  • Managing the Regulatory activities and supporting the product care activities of the assigned product portfolio

  • Assessing and communicating regulatory risks and challenging the project and lifecycle teams

  • Consulting and actively supporting the Project teams during the development of new products and the product lifecycle regarding regulatory and design quality assurance aspects

  • Accomplishing conformity evaluation for new and existing products

  • Planning of Deliverables with other Regulatory Affairs professionals (USA, Canada, China etc.) for product registrations, including compilation of corresponding Software- and Hardware-Reports

  • Providing insights into upcoming regulatory changes and trends prior to the issuance of new guidance, standards, laws, or regulations

  • Ensuring the interface between RDI and Regulatory Affairs teams for product approvals/clearances in the various regions (USA, Canada, China, etc.)

  • Managing the Regulatory activities for the IVDR implementation of the assigned portfolio

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

  • You hold a university degree (e.g., Engineering, Natural Sciences, IT, etc.) with further education in Regulatory Affairs

  • You are experienced in Regulatory Submissions and Project Support

  • You are experienced in the regulatory framework in Medical Devices with ideally good know-how of IVD/Medical Devices Directives and Software Development 

  • You gained knowledge of design control requirements for In Vitro Diagnostic/Medical Devices (Software, instruments and analytical systems)

  • You are able to think strategically and set concrete objectives

  • You are a proficient presenter and negotiator in English and preferably also in German

  • You have willingness to travel