Competitive salary of up to £25,000 depending on experience
Armley Leeds LS12
Do you want to work for a vibrant company helping to improve healthcare around the world?
This is a great opportunity for an organised and enthusiastic Regulatory Assistant to join one of the fastest growing and exciting healthcare companies in the marketplace!
Optimum Medical is one of the UK’s leading healthcare manufacturers. Our products are supplied to every single NHS hospital in the UK as well as being exported to over 60 countries worldwide. Our company mantra is ‘constantly creating better’ because we aim to do just that. We are looking for the right person with a passion for success to join our Leeds based team.
Reporting to the Regulatory Manager, the Regulatory Assistant will carry out the following tasks:
· Prepare and update CE technical documents for existing devices in-line with MDR requirements
· Collaborate with multifunctional teams to provide regulatory support for new projects, product labelling and new/lifecycle applications to regulatory authorities and notified bodies
· Assist in monitoring and reporting post-market activities of devices as per MDR requirements
· Support registration activities and regulatory submissions in international markets
The successful candidate will be efficient, well organised and have a systematic and methodical approach to their work. They will have a positive ‘can do’ attitude.
Full product training will be provided and the role will be based in Leeds.
- A minimum of 3 years regulatory experience within medical devices
- Working knowledge of ISO 13485 and ISO 9001
- Excellent written and verbal communication skills
- Excellent accuracy and attention to detail
- Capable of working on multiple projects, both independently and in a team environment
- Ability to critically evaluate and summarise complex data into simple messages and actions
- Prepared to build networks and alliances with peers and external partners
· A degree in a relevant scientific discipline, or equivalent experience
· Competitive salary of up to £25,000 depending on experience
· 27 days holiday
· Health cash plan
· Cycle to Work scheme
· Free onsite parking
Optimum Medical can offer you an environment geared towards performance, attractive career opportunities, and an open culture that values and rewards the contribution of every individual.
Potential candidates will be assessed against our company values to make sure you are the right fit for the business.
At Optimum Medical we LISTEN, we CREATE, we MAKE IT HAPPEN, we CARE and we HAVE FUN!
How to apply
If you would like to apply for this position please send your CV and a cover letter to quoting ‘Regulatory Assistant’ in the subject line.
The closing date for applications is 31st January 2018
Constantly creating better