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Regulatory Affairs Manager

Volt Europe Ltd
Closing date
7 Jul 2022

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Contract Type
Full Time
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An opportunity to work in an exciting job opportunity to work alongside the NHS to bring forward health care and research to help people live longer and healthier lives with ground breaking areas of medicine that uses there unique genetic code for this.

They also equip researchers to find the causes of disease and develop new treatments with patients and participants at the heart of it all.

They are looking for a Hybrid based Regulatory Affairs Manager to be responsible for establishing and managing all aspects of regulatory compliance , while having expert knowledge of medical device regulations.

You will need to following experience for the role:

Expert knowledge of the medical device regulations such as IVDD, IVDR and MDR.
Demonstrable understanding of of harmonised ISO standards
Proven experience with working with software as a medical device (SAMD)

In the job role you will be doing the following key things:

Ensure the medical device requirements are met and maintained throughout the product development lifecycle
Ensuring the compliance of the technical file content for the product according to regulatory requirements for the medical device.
Support all Quality Management System related activities including but not limited to audits, nonconformity management, document control activities, PMS/PMCF, complaints and incident management etc
Support in the preparation and execution of audits both internal and external
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