Description
These roles are to ensure compliance with the regulatory processes, procedures and getting products to market. This will include the building and maintenance of the (QMS) Quality Management System, implementing processes for internal research and development, clinical trials and facilitating meetings with the Regulatory Authorities in Europe and the United States.Desired Skills & Experience
The successful candidate will have 5 years+ relevant experience in Regulatory Affairs/QA/QC within the medical devices OR diagnostics industry. As the only point of contact for RA/QA, the candidate will be expected to have a complete understanding of 510(k) / Pre-IDE / IDE / PMA submissions. There is scope for this contract to extend and form part of a Regulatory team, as Regulatory Manager, when the products are closer to market.
Recent working experience of managing Global Registrations and Strategies, with a comprehensive understanding of ISO13485 & 21 CFR is essential.
The position will also involve Technical file compilation and review (IVD/MD), Risk Management to ISO 14971 and US FDA. A full understanding of the development process for medical devices OR diagnostics products.
It is expected that the successful candidate will be able to bring an established network of relationships with MHRA, FDA and other regulatory bodies.
If you are interested in this position, or if you are available for similar projects in the future, please contact Duncan Cameron on .