Description
- Prepare and submit European (CE Marking) and FDA (510k) applications for the authorisations to market new products
- Map out the regulatory requirements for new markets including China, Japan, Russia and the Middle East
- Establish and maintain relationships with regulatory authorities including the MHRA and Notified Bodies regarding clinical trials and submissions
- Liaise with internal stakeholders on the changing regulations and how these will impact the business
- Assist the Quality Team on hosting audits and partaking in internal audits
- Ensure regulatory compliance from design and development through to vigilance and post market activities.
Skills/Experience
- Several years working in the Medical Device/IVD market
- Experienced in CE Marking a product
- Ideally class III medical device experience, however, this is not essential
- Ideally 510(k)/FDA experience
I am currently arranging interviews for this position so if you believe you have the correct experience and are keen on joining an exciting new business then please send me your CV and I will be in touch shortly.