Technical Lead / Software Development Lead SaMD
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Hobson Prior are looking for a Technical Lead / Software Development Lead SaMD for an exciting contract position to join a world-wide pharmaceutical company based in Switzerland with the ability to work from home. Our client focuses on providing pioneering medical solutions to improve the quality of people's lives.
- Technical leadership for the software development of mobile and/or web applications classified as SaMD.
- Supporting the standardization of the entire SaMD life cycle management process in order to utilize cross product synergies.
- Providing software/systems life cycle expertise within a broader cross functional drug product development team.
- Leading the collaboration with external development partners.
- Leading and/or 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.
- Team player who works efficiently in interdisciplinary teams.
- Good communication and conflict management skills.
- Fluency in English language incl. technical writing Experience desired.
- Proficiency in German.
- Analytical thinking and problem?solving capability.
- MSc/MA in computer science or relevant field and excellent understanding of the current Agile development methods and technologies.
- Experience in project / program management of complex projects.
- Autonomous and independent working style with at least 7 years of experience as technical, project management of projects with safety critical applications in a regulated environment.
- Experience in designing innovative software and systems architectures.
- Excellent understanding of software design and programming principles as well as in overall verification strategies, including test set up and test automation.
- Considerable experience of managing external suppliers.
- General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements.
- Understanding of 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)
- Development and writing of technical documentation of drug/device combination products and medical devices, including the design control process and other applicable regulatory, QA and GMP aspects.
- Understanding of pharmaceutical development in general.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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