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FREELANCE: Lead Application Developer - Human Factors/SaMD

Posted on Oct 10, 2020 by Umbilical

Basel, Switzerland
IT
1 Oct 2020
Annual Salary
Contract/Project


Human Factors/Software as a Medical Device - SaMD

#15578 | 12 month+ contract | Switzerland

James Carrera at Umbilical has partnered with a Global Pharmaceutical client to source an Expert Application Developer to support the expansion of SaMD, acting as technical leader for software development in Medical Device Development.

Accountable for:

Technical leadership for the software development of mobile and/or web applications classified as Software as a Medical Device (SaMD), providing software/systems life cycle expertise within a broader cross-functional drug product development team, as well as;

  • Supporting the standardization of the entire SaMD life cycle management process to utilize cross-product synergies,
  • Collaboration with external development partners: Selection and vendor management
  • Leading/supporting cross functional project teams during development, review and submission of regulatory dossiers,
  • Leading risk management activities,
  • Planning and monitoring of design verification activities,
  • Leading and authoring technical documentation,
  • Ensuring a high-quality Design History File,
  • Supporting the improvement of the SaMD QMS.

Qualifications:

Educated to MSc/MA in computer science or relevant field and excellent understanding of the current Agile development methods and technologies, as well as;

  • 7 years of experience as technical, project manager of projects with safety critical applications in a regulated environment,
  • Designing innovative software and systems architectures, software design and programming principles, overall verification strategies, including test set-up & automation
  • Fluency in English & German language incl. technical writing Experience desired,
  • Human Factors Engineering, risk management/clinical studies
  • Medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation), including those related to medical software (IEC 62304)
  • Technical documentation of drug/device combination products and devices, design control process and other applicable regulatory, QA and GMP aspects

For a confidential discussion, contact James Carrera at Umbilical

Reference ID: 15578

Contract length: 12 months

Job Types: Full-time, Contract




Reference: 968037875

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