Schweiz, Zug, Rotkreuz RDI
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Manages the Regulatory activities and supports the product care activities of the assigned product portfolio
Assesses and communicates regulatory risks and challenges to project and lifecycle teams
Consultancy and active support of the Project teams during the development of new products and the product lifecycle regarding regulatory and design quality assurance aspects
Accomplishes 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
Provides insights into upcoming regulatory changes and trends prior to the issuance of new guidance, standards, laws, or regulations.
Ensures the interface between RDI and Regulatory Affairs teams for product approvals/clearances in the various regions (USA, Canada, China, etc.)
Works in a cross-functional, multi-site team to ensure alignment and harmonization
Manages the Regulatory activities for the IVDR implementation of the assigned portfolio
To be successful in this role you will have at minimum a University degree (e.g., Engineering, Natural Sciences, IT, etc.) with further education in Regulatory Affairs
Additionally, you...
bring along at least 3-5 years of experience in Regulatory Submissions and Project Support
are experienced in the regulatory framework for In Vitro Diagnostic Medical Devices with good know-how of IVD/Medical Devices Directives and Software Development
gained knowledge of design control requirements for In Vitro Diagnostic/Medical Devices (Software, instruments and analytical systems)
are able to think strategically and set concrete objectives
are a proficient presenter and negotiator (fluently in English and preferably also in German)
call yourself a strong team player with resilience and high self-esteem