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- Explore strategies
- Compliance in line with regulatory requirements
- Document management
- Write and maintain (update and review annually) risk assessments and support the maintenance of the device risk management files and overall risk management activity across the product lifecycle (e.g. to ISO14971
- Write and maintain product submissions to relevant regulatory agencies (CE Notified Body, FDA,HealthCanadaetc.).
- Assist the QSM with the calibration management activities
- Manage post market surveillance activities
- To ensure that they are appropriately trained for the task they are to perform.
- To ensure that the activities they conduct are in accordance with the quality system SOPs and company quality policy.
- To ensure that they maintain and continuously improve their understanding of the international regulatory systems that apply.
- Creating necessary documentation to achieve the areas outlined above.
- Investigating / assessing issues in order to achieve the areas outlined above.
- Planning (including interfacing with colleagues) and executing such plans in order to achieve the areas outlined above
Please get in touch to understand this role further.
If this isn't suitable for you, do you know anyone that potentially would be?
We offer £200 referral vouchers for any successful referral.
KEYWORDS: DEVICES, MEDICAL DEVICES, 13485, 14971, ISO14971, REG, SPECIALIST, DEVICES, MED DEV, DEVICES, REGULATORY
To find out more about Real Staffing please visit www.realstaffing.com