Switzerland, Zug, Rotkreuz RDI
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Head of CPS/SIS Regulatory Affairs, RDI We are looking for an experienced and energetic -
, who provides strategic direction on Regulatory tasks for the assigned organizations in Rotkreuz. As the role has a critical interface with key organizations within Roche Diagnostics, this means a high degree of influence over a variety of products being developed or led out of the organization. In this role, you act as the Regulatory decision maker for any escalated Regulatory Affairs Relevant issues and are a member of the CPS/SIS Regulatory Affairs leadership team. As Head of CPS/SIS Regulatory Affairs at RDI, you have the liberty to create and perfect a responsible and focused work culture oriented on best customer support.
The responsibilities in this role include (but are not limited to):
Functional management of Regulatory activities within certain business areas
Implementing and monitoring projects developed together with the CPS/SIS Global Regulatory leadership team
Managing and supporting the Rotkreuz site in the area of Regulatory activities for the assigned IVD products
Make sure that typical processes in a Regulatory area are defined and correctly followed
Coordination of assigned project support/submissions activities coming from Rotkreuz site as well as others
Maintains appropriate communications with the applicable Regulatory authorities, notified body and/or registrar worldwide, and responds to communications with local Regulatory authorities, as applicable;
Provides recommendations on budget and personnel requirements for their respective Business Areas, Global Function and/or site(s)
To be successful in this role, your profile ideally includes:
Master of Science or Engineering degree in scientific discipline or related field
3 + years’ experience in Regulatory submissions for Hardware and Software in the area of medical devices (e.g. IVDs)
Ideally experience in Life Cycle Management and in multifunctional / global teams (direct /indirect)
Expert communicator, and ability to influence various, complex internal/external stakeholders in a matrix environment
English proficiency and regional language proficiency
Ability to work in a fast paced environment and manage high workloads through effective techniques such as prioritization and delegation