Regulatory Affairs Specialist - 510K Submissions - £40,000

Recruiter
Hamlyn Williams
Location
Birmingham
Salary
£35,000 per annum
Posted
30 Aug 2017
Closes
22 Oct 2017
Sector
General
Contract Type
Full Time

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.