Quality Manager (Fixed Term)

Would you like to be instrumental in the development of medical devices emanating from the University of Cambridge and associated hospitals?

Academic research at the University of Cambridge has produced numerous statistical and AI-based tools including clinical decision support tools, prognostics and diagnostics which could become Software as Medical devices (SaMDs).

As a Quality Manager, you will ensure successful product regulatory readiness to achieve clinical impact through market access to benefit patients. This role requires a detail-oriented individual with a desire to drive continuous improvement in quality processes to document medical device development effectively, develop Quality Management Systems (QMS) procedures & processes and produce Technical Files.

You will work closely with academics who are developing medical devices/SaMDs/AIaMDs, guiding them in assembling and maintaining complete, audit-ready technical documentation for SaMD across the full software lifecycle and cybersecurity hardening. You will act as quality contact, translating regulatory and QMS requirements into practical, project-level plans, checklists and templates that academic teams can follow, ensuring compliance in line with notably EN ISO 13485:2016, EN ISO 14971:2019, EU MDR, UK MDR, and other applicable regulatory frameworks as appropriate to the needs of the projects of the University.

We are seeking a proactive and solution-focussed individual. Applicants will have a scientific degree as well as direct experience of working in regulatory affairs or quality management systems relating to SaMDs

The post holder will be an employee of the University of Cambridge Office for Translational Research in the regulatory Hub and be a member of the School of Clinical Medicine. 

Applications should include a covering letter outlining suitability for the position and CV. Informal enquiries may be directed via email to Reza Salek

Fixed-term: The funds for this post are available for 2 years in the first instance.

To apply online for this vacancy and to view further information about the role, please click the 'Apply' button above. 

Please ensure that you upload a covering letter and CV in the Upload section of the online application. The covering letter should outline how you match the criteria for the post and why you are applying for this role. If you upload any additional documents which have not been requested, we will not be able to consider these as part of your application.

Please include details of your referees, including email address and phone number, one of which must be your most recent line manager.

Please quote reference ST48444 on your application and in any correspondence about this vacancy.

The University actively supports equality, diversity and inclusion and encourages applications from all sections of society.

The University has a responsibility to ensure that all employees are eligible to live and work in the UK.

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