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Regulatory Affairs Manager IVD Hardware/Software

Who We Are

Roche Diagnostics International Ltd in Rotkreuz is one of the world’s leading providers of diagnostic system solutions for clinics, laboratories and doctors’ offices. The company employs over 2200 people in Rotkreuz and is one of Roche Diagnostics main sites.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

The Position

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.
This role is responsible for 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. Responsible for assessment of device changes for regulatory implications.

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
  • Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations
  • May review, interpret, and report 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
  • 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

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.

To be successful in this role (you have to):

  • Posess a degree in Science, Engineering, or related technical field required
  • 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

Roche is an equal opportunity employer.

Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

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