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Risk Management Specialist

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    Alex Podolski

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    etwa 10 Stunden her


Austin Vita are currently working with a global Medical Devices company, who are embarking on a large-scale regulatory transition. They require a Risk Management Specialist to come in, for a circa 6 month period (with a view to extend) to ease the strain on the department.

The role is focused around the compilation, and remediation of Risk compliance documentation, in particular to ISO 14971 and compiling FMEA and pFMEAs.

The type of relevant experience/expertise includes:

- Strong ISO 14971 exposure and familiarity

- ISO 13485 background (within either Medical Devices OR IVDs)

- Advanced FMEA/pFMEA comprehension and familiarity

- Demonstrable Design Control experience (and defining inputs/outputs)

This role is, for the most part, remote. However, there could be a requirement for some on-site working later down the line for project meetings - however this will be very infrequent.

If any of the above matches your background, please do not hesitate to apply and I will get in touch shortly after.

Austin Fraser is acting as an Employment Business in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.