Regulatory Affairs Specialist Medical Devices UK - Expired
|Job Title||Regulatory Affairs Specialist Medical Devices UK|
|Salary||£50000 - £60000 per annum + Bonus, healthcare, pension, etc|
|Location||Leeds, West Yorkshire|
|Job Advertised||over 2 years ago|
Regulatory Affairs Specialist Medical Devices
Exciting opportunity for an experienced Regulatory specialist with experience in Regulatory Affairs and FDA to join a global medical device company based in Leeds, the UK offering a salary in the region of £45-£60K + benefits
As a regulatory specialist you will be supporting all registration activities, CE marking and regulatory submissions as per project requirements.
Working as part of a global team your responsibilities as Regulatory specialist will be:
- Facilitating worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies.
- Ensuring post marketing surveillance responsibilities are fulfilled and support vigilance activities.
- To maintain information on worldwide regulatory requirements and the status of product registrations.
- To Review technical documentation created by teams based remotely and ensure these are complete and accurate.
- A graduate engineering/science degree.
- Good experience in Regulatory Affairs, preferably in Medical Devices.
- Knowledge and experience in EU and FDA regulations
- Regulatory Affairs certification (like RAC) is beneficial
- Strong knowledge in the application of MDD93/42/EEC
- Exposure to change management
This Regulatory Affairs Specialist role offers a competitive package in the region of £45000-£60000 based on relevant experience along with a bonus, healthcare, pension, education support +++ with excellent career advancement opportunities.
To apply for this Regulatory Specialist role email CV in the strictest of confidence to Som in Principle on firstname.lastname@example.org or call 00353 1 603 5075