Regulatory Affairs Manager IVD Hardware/Software (m/f/d)

Germany, Baden-Wurttemberg, Kornwestheim

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Roche Diagnostics Automation Solutions (RDA), formerly Roche PVT, in greater Stuttgart is one of Roche's competence centers for the development and production of laboratory automation systems. The automation solutions from Roche Diagnostics play a key role in making laboratory results quickly and safely accessible to doctors and patients. At RDA, we bring all technical disciplines together to develop the next generation of laboratory automation systems.

This Regulatory Affairs function belongs to the Roche Centralised and Point of Care Solutions (CPS) business area and supports in addition DIA Solution Integration and Services. As Regulatory Affairs we support instrument and systems projects and the related product portfolio.

As Regulatory Affairs Manager IVD Hardware/Software (m/f/d) , you conduct activities associated with regulatory approval of 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. This role is responsible for the assessment of device changes for regulatory implications. You will act as the regulatory affairs expert at RDA and will be the central point of contact for questions of different stakeholders concerning regulatory matters. Training and consulting the organization on regulatory topics will be one of your focus areas.

You will be working in Kornwestheim until the end of 2021 – then the site will be permanently moving to Ludwigsburg.

The advertised position offers:

  • Provides support to currently marketed products, manages the regulatory activities and supports the product care activities of the assigned product portfolio e.g., review changes, labeling, promotional material, product changes and documentation for compliance on your own authority
  • Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations
  • Review, interpretation and reporting of Regulatory leadership on product specific regulatory issues that may have impact on the business units, the corporation, or the customer. May work with Quality department to influence mindset of quality
  • Consultancy and active support of the R&D project teams during the development of new products and during the product life cycle
  • Education and training of the organization in regards to regulatory topics
  • Assesses and communicates regulatory risks and challenges, interfaces with the lifecycle team
  • 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
  • Ensures the interface between Roche (Rotkreuz) 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

What else awaits you:

  • Our R&D site in Kornwestheim is characterized by dynamism and agility. We have clear goals in mind and plenty of room for creativity thanks to our medium-sized company, but at the same time we have the security that the Roche Group provides
  • RDA employees are asked to contribute courageous and unconventional ideas and thus actively shape the success of the company
  • We are passionate about our work and motivated by what we do: Doing now what patients need next

To be successful in this role you:

  • Possess a degree in Science, Engineering, or related technical field
  • Bring along 3-5 years of experience in Regulatory Submissions and Project Support, preferably in the area of regulated instrument and software development
  • Are experienced in the regulatory framework for IVD Medical Devices and/or Medical Devices with good know-how of IVDD/VDR and international regulations for IVD devices
  • Gained knowledge of design control requirements for In-Vitro Diagnostic (Software, instruments, analytical systems and solutions)
  • Are able to think strategically and set concrete objectives
  • Are able to act as an interface between the relevant stakeholders and tailor the communication style based on the audience
  • Enjoy networking across different functions and have facilitation skills
  • Select the right level of details and simplify complex topics
  • Speak and write fluently in English (German language skills are beneficial)

Your application:

Please upload your current CV, letter of motivation and relevant certificates / references. Before sending your application, please note that no further documents can be added subsequently.

Further information can be found at https://www.roche.de/about/standorte/waiblingen/index.html

We accept English and German application documents

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Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs