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Regulatory Affairs Manager (m/f/d) 100%

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Regulatory Affairs Manager (m/f/d) 100%

For our international partner, Roche Diagnostics International Ltd. based in Rotkreuz, we are looking for a qualified and motivated Regulatory Affairs Manager from November 2019 to March 2020.

The Regulatory Affairs team belongs to Roche Solution, Integration and Services (SIS) which is responsible for the optimization and automation of processes. The contractor Roche is looking for will support the Pre- and post-analysis of electrical medical devices in relation to Hardware and Software instruments. This mature regulatory role is responsible for the overall development, implementation and coordination of regulatory strategies and activities with focus on software products and projects. The Rotkreuz department (Team of 4 members) is responsible for requirements related to platforms developed with internal and external partners.

Tasks

  • Manages the regulatory activities and supports the product care activities of the existing and authorized product portfolio within SIS Workflow and IT Software/Hardware Projects, No Assays
  • Assesses and communicates regulatory risks and challenges to project teams and interfaces with the lifecycle team (There is no contact with the regulatory authorities)
  • Consultancy and active support of the RundD project teams during the development of new products and during the product lifecycle
  • Accomplishes conformity evaluation for new and existing devices
  • Planning of Deliverables with other Regulatory Affairs professionals 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 (MDR/IVDR)
  • Ensures the interface between Roche (Rotkreuz) and Regulatory Affairs teams for product approvals/clearances in the various regions and fulfillment of requirements
  • Works in a cross-functional, multi-site team to ensure alignment and harmonization

Must Haves

  • 5 years or more of experience as Regulatory Affairs Manager in electrical medical devices
  • Experience with Development and Software of IVDR Instruments
  • Mechanical/Electrical Expertise
  • English

Nice to Haves

  • Bachelor or Master with technical or electrical background
  • Spanish and German is a plus

Based on your experience and education, the salary range is between CHF 140'000.- and CHF 170'000.-.

Are you interested? Do not hesitate and submit your complete application documents online today.

We value diversity and therefore welcome all applications - regardless of gender, social origin, religion/belief, age or identity.

We also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!

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Paolo Gulleri

Overall rating

5,0

Based on 1 reviews

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