Senior Regulatory Affairs Officer
Hybrid working from Edinburgh office
Offering up to £55,000 Per Annum, plus bonus and benefit package
CPL Life Sciences has partnered with an organization who has over 30 years history working in the in-vitro diagnostics field. Headquartered in Edinburgh this organization is looking for an experienced Senior Regulatory Affairs Officer to join their established Regulatory team. Under the direction of the Head of Department you will be responsible for building strategy, determining regulatory requirements and managing product license registrations with global authorities. Additionally, this role will be responsible for ensuring post market surveillance and vigilance reporting obligations are met.
Job Requirements include;
- Maintaining regulatory compliance processes including, regulatory evaluation of changes and non-conformances, post-market surveillance, vigilance and associated reporting, regulatory and standard watch
- Preparing and compiling regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO13485, IVD 2017/746
- Ensuring Post-market surveillance obligations are met and maintaining the post-market surveillance process.
- Leading and coordinating the vigilance process in interface with the complaint handling process
- Providing support to the Department Leader of Regulatory Affairs with regard to planning and co-ordination of activities and with regard to training and supervision of other members of the Regulatory Affairs team and to ensure continuous development of junior staff to develop their capabilities.
Candidate Requirements include;
- Eligibility to live and work in the UK
- A life science degree or equivalent field of study
- Experience in a medical device/ IVD or biotech industry
- Previous experience preparing and submitting BLA, 510(k), PMA, CE mark and technical files to other worldwide regulatory authorities
- Previous knowledge of vigilance processes for US & EU affiliates
If this position is of interest to yourself please forward your up to date CV to sophie.malyon@cpl.com.
