- YOU will be responsible for collaborating with Regulatory and Quality functions to align on the interpretation of the requirements for Medical Devices
- YOU will have to identify processes to allow proactive collection of customer feedback that will feed into the Post Market Survilllance process to meet the requirement of ISO13485 and Medical Device Regulation.
- YOU will also provide support to TPC team members on ensuring current implementation of Use error handling allows correct complaint intake, trending and feedback into specification and risk management in line with the expectations of ISO13485, Medical Device Regulation and combination product Medical Device Reporting and usability requirement. .
SOME TASKS :
*Assess current post market activities to understand scope of how feedback is received, captured, trended and fed back into various teams and assess gap against various Medical Device and combination product requirements
*Ensure correct implementation of updated design control and risk management procedures to design/ risk management documents for medical device and combination device.
*Ensuring correct implementation of feedback loop from Use error and feedback to allow correct classification, trending and input into usability, performance and safety requirements in line with the expectations of ISO13485, EU Medical Device Regulation, combination product Medical Device Reporting and Human Factors and Usability requirement.
*Establish processes required and ensure implementation in QMS for the applicable Medical Device product in line with the expectations of ISO13485 and EU Medical Device Regulation.
- Engineering Degree or Biomedical or Medical Devices
- Experience in Medical Devices process implementation
- Experience in Post Market Activities for highly regulated devices
- Fluent in English, any further language is an advantage