about 1 year ago
The Regulatory Specialist will also provide support with the application for the FDA 510(K) process.
*To ensure that the Technical Files created as a requirement for the maintenance of the company's CE status is maintained
*To aid with regulatory compliance in other Markets (US) to which devices manufactured will be introduced.
*To provide support with the application of market specific QMS requirements eg. ISO 13485, FDA 21 CFR Part 820, etc.
*To provide support with the application for the FDA 510 (k) process
*To maintain and/or initiate new clause compliance documents based on the standards and directives applicable to the markets in which the company will be introduced.
*Selection of suitable strategies for Regulatory submissions in all markets.
*3-4 year experience with different pathways for FDA submissions, specifically that 510(k( and the associated selection of predicate devices.
*A relevant degree, preferably in Science or Engineering, minimum of 2.1
*Experience with Medical Devices.
*Experience with the construction and maintenance of a Technical File as required CE.
*Experience implementing a MDD
*An ability to use general office software (Microsoft Office) and other specialised software as required.
*A flexible approach to the tasks, work part of a team, attention to details is essential.
*Communicate in an effective and credible way.
*Can do attitude, resilience and flexibility to work in a busy and changing environment.