Quality and Regulatory Affairs Manager (Fixed Term)

We are looking for a Quality and Regulatory Affairs Manager to join an exciting programme of work (CanRisk www.canrisk.org) on the development of cancer risk prediction tools for breast, ovarian and prostate cancer, funded by Cancer Research UK. The main objectives of the programme are: (1) to develop and validate tools for cancer risk-stratification and prevention that take advantage of discoveries in both cancer genomics and epidemiology; and (2) to enable cancer risk prediction within routine front-line healthcare to facilitate the identification and management of at-risk individuals and promote cancer prevention and early detection.

The successful applicant will work within a team of researchers and software developers at the Centre for Cancer Genetic Epidemiology, Department of Public Health and Primary Care, University of Cambridge. They will have overall responsibility for quality assurance (QA) and regulatory affairs (RA) work within the group. This work is vital in order for us to place and maintain our software products on the UK/EU/US markets.

Applicants for this position should have:

• STEM first degree (BEng, BSc) or have equivalent qualifications.
• Knowledge of ISO 13485 and UK/EU regulatory requirements for medical devices.
• Experience of managing ISO 13485 QMS
• Knowledge of medical device qualification/classification
• Experience of placing/maintaining medical devices on the UK/EU markets
• Recent QMS audit and audit training experience
• Good written English and Microsoft Office skills
• Great attention to detail and planning/communication skills.

The position is full time and funds are available for this post for 2 years from date of appointment in the first instance

Location - Department of Public Health and Primary Care, Strangeways Research Laboratory, Worts Causeway, Cambridge CB1 8RN

Informal enquiries can be made by email to Professor Antonis Antoniou (aca20@medschl.cam.ac.uk)

To apply online for this vacancy and to view further information about the role, please visit:

http://www.jobs.cam.ac.uk/job/36327.

Closing Date:  29 August 2022

Interview Date: w/c 5 September

Please ensure that you upload a covering letter and CV (including the names of two people who can provide a letter of reference) in the Upload section of the online application. The covering letter should outline why you are interested in the post.

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

Please quote reference RS32547 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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