RA Associate - Pre Market

RA Associate - Pre Market
  • £26,000 - £34,000 per Annum
  • Permanent
  • Winsford, Cheshire, England, UK Winsford Cheshire UK CW7 3RT
Job Ref: J2161892
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 14 September 2021
We have a great opportunity for a career-driven individual to join a world-leading company that develop and manufacture a range of innovative and tech

You would be working in pre-market for the surgical care business unit mainly remote working, but you are required to go onto the Winsford site intermittent. You will be collaborating with a variety of departments both internally and externally to ensure all regulatory reports and documentation is compliant with relevant requirements. As a Regulatory Affairs Associate some of your key responsibilities include:

  • Generation of Regulatory Documentation for submission to European and USA Regulatory Authorities of new product developments and changes.
  • Maintain the Pre-Market and Product Life Cycle processes and SOPs.
  • Support product performance and manufacture process improvement programmes, to ensure compliance with 93/42/EEC, 2017/745 and 21 CFR Part 820 requirements.
  • Support the creation of European and USA Regulatory Strategy documentation for new product developments and changes to existing devices.

As the ideal candidate, you will have a degree or equivalent, in a Life Science, or similar industry experience. Knowledge and understand of FDA Quality System Regulation and ISO 13485, relevant GMP and European Medical Devices Regulation (MDR). You will be analytical, able to work under pressure and have excellent communication skills both written and verbal. Having experience maintaining technical files and working within a regulated industry is essential.

14/10/2021 13:05:00
GBP 26000 34000 Annum

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