Rate: £ 400 per day (in Scope)
Contract Length: 6 Months
Location: Home based / Remote
- Regulatory specialist to participating in the day-to-day compliance/ regulation activities relating to medical devices and IVD devices
- Contribute to the development, implementation and maintenance of the medical devices quality management system for the entire product lifecycle.
- The Regulatory Specialist will also be expected to work closely with the Product Development team on any quality related issues and ensure the appropriate steps are taken to minimise disruption to the overall supply chain by coordinating with the logistics providers.
- Provide Risk Management technical expertise through the product life cycle
- Support development, remediation and maintenance of Risk Management Files according to ISO 14971 and MDR requirement
- Train and support risk management activities related to new product introduction (NPI)
- Participate in or manage quality assessments of internal operations and suppliers to analyse compliance and assess risk
- Participate in complaint investigation, including definition of investigation level, root cause analysis, timeliness and quality of response and trending
- Participate in the review and recall of defective product, as necessary, in order to minimise patient risk
- Facilitate development and completion of risk assessments for field issues/complaints in the field.
- Work with cross-functionally to ensure the accurate application, use and updates of risk management files
Key skills/Experience required:
- Regulatory experience is critical - iso14971 and iso13485 (essential),
- Experience with Medical device Manufacturing / quality (MDD & IVD Experience)
- In-depth knowledge of European Medical Device Directive and the new Medical Device Regulation. (MDD)
- Medical devices and quality experience
- Technical File experience
To apply for this role please submit your latest CV or contact Aspect Resources on 0121 794 8181