Senior Regulatory Executive (Medical Device Regs)
- Ware, ENG (GBR)
- £450 - £525 Per Day
- 12 Months
- Start date: ASAP
- Ref: GSK0JP00078373
- Pharma - Regulatory Affairs
- medical device
- risk assessment
- medical device regulations
Senior Regulatory Executive (Medical Device Regs)
GSK Ware
12 Month Contract
up to £525 per day
Role:
The Medical Device Professional role will be report to the Project Manager and will be responsible for the generation of Technical Files and Process files to comply with the EU Medical Device Regulation (MDR) No. 2017/745 for a range of current devices. The Medical Device Professional will work within a project team to bring both files and processes in line with current Medical Device Regulations. The role will require flexibility and ability to adapt to the resource needs of the business.
- GSK are looking for someone with significant experience in medical device compliance (10-15 years experience)
- There have been new medical device regulatory changes for the EU, meaning all the documents need updating
- Devices are primarily respiratory devices - working experience with respiratory devices would be advantageous
- The individual should have experience and an understanding of risk assessment – should be able to run a risk assessment, not just be part of one
- Experience from working in a large organisation
- Device development background is advantageous
All profiles will be reviewed against the required skills and experience. Due to the high number of applications, we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply.
