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Regulatory Affairs Manager- IVD Software Development

Posted on Oct 10, 2019 by Randstad (Schweiz) AG

Zug, Switzerland
Research
Immediate Start
£600 - £800 Daily
Contract/Project

For a international pharma company we are looking for a Regulatory Affairs Manager to join our clients team. We are looking for someone with experience with development and software of IVDR Instruments.

Background: The Regulatory Affairs team is responsible for the optimization and automation of processes. The contractor we are 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 department is responsible for requirements related to platforms developed with internal and external partners.

This is a contract position until March 2020. However, our client is looking for a permanent solution.

Main Tasks:

  • Manages the regulatory activities and supports the product care activities of the existing and authorized product portfolio and IT Software/Hardware Projects, No Assays

  • Assesses and communicates regulatory risks and challenges to project teams and interfaces with the life cycle team (There is no contact with the regulatory authorities)

  • Consultancy and active support of the R&D project teams during the development of new products and during the product life cycle

  • 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)

  • Works in a cross-functional, multi-site team to ensure alignment and harmonization

Your profile

  • 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

  • Fluent in English

  • Bachelor or Master with technical or electrical background

If you think this could be an interesting role for you! Then don't wait (as this is an urgent role) either send me your application or else feel free to call me and we can have a short call to share more details regarding the role.

Reference: 770799954

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