Regulatory Affairs Specialist - 510K Submissions - £40,000
I am seeking an individual that to join a growing team:
- Knowledge of FDA 21 CFR 820 - 510k process, IVDD - CE marking and ROW regulations/registration processes.
- This individual must offer general advice on regulatory strategy for new products and product changes
- Must be able to complete a 510k submission with minimal supervision.
- They will undertake CE marking activities and has a good understanding of the requirements of the IVD Directive.
- This individual must be able to recognize post market surveillance issues that require corrective action and reporting.
- They will liaise directly with international regulatory agencies and provide supporting documentation, handle queries and issues
- To contribute to the development and implementation of regulatory policies, procedures, and specifications across the company and ensuring that these are compliant with the Quality System.