7 months 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.