Regulatory Affairs Engineer - Post Market Surveillance
£40,000 - 45,000
A globally recognised engineering company within the Medical Devices industry are looking for a Regulatory Affairs Engineer. Working in modern high tech offices you will be working for a company with a global product base and huge appeal. Their product range in the Medical Device field is imperative and their employees are highly motived to continue the important and morally strong work they do.
Your main task will be support the companies'processing compliants and field corrective actions, communicating with the Regulators and Notified Bodies to support the process activities.
Post Market Surveillance Responsibilities
+ Draft appropriate Adverse Event reports using eSumbitter & EU Medical Device Vigilance Forms for review
+ Submit Adverse Event reports within reporting timelines
+ Ensure records are kept upto date and miantain the Events tracker
+ Process follow up and final reports
+ Monitor the GPMS mailbox
+ Coordinate and send recall reports to Authorities, Internal RA.QA, Distributors, and Notified Bodies
You have a Master / Bachelor of Science degree (Medical, Mechanical, Electrical, Industrial Engineering, etc.) or equivalent engineering degree. Expert knowledge and proven track record in Regulatory Affairs for Medical Devices
Please apply now!