Regulatory Engineer- Medical Devices
Regulatory Engineer- Medical Devices Crawley Working as a Regulatory Engineer you will gain exposure to working on a wide variety of products that are making significant contributions to people across the world, used in a range of hi-tech applications in the medical industry. Although the company are not a start-up they do have a small business community feel where you will have the opportunity and freedom to help shape regulatory and quality procedures for years to come. This role will sit within a small team and will focus on establishing that regulatory requirements are met for new product introduction and design changes to established products. Some other responsibilities will include: - Ensure that design validation protocols contain the regulatory supporting evidence needed in order to move forward. - Work closely with R&D to ensure all testing certification and compliance are all in place. - Assure the integrity of the design history file and technical file prior to regulatory ; - Conduct research into regulatory deliverables for development ; - Ensuring compliance with ISO 13485 FDA ; For this role you will need: - Experience of working as a regulatory engineer within the medical device or life science sector. - Experience of ISO13485 - Experiance working with IEC 60601, IES 62304 - Knowledge of risk management and design validation ; - An understanding of testing approaches related to medical devices.