Regulatory Engineer- Medical Devices
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|Sector||Manufacturing - Scientific|
|Salary||£40000 - £45000 per annum|
- Regulatory Engineer- Medical Devices
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 filings.
- Conduct research into regulatory deliverables for development projects.
- Ensuring compliance with ISO 13485 FDA standards.
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 approaches.
- An understanding of testing approaches related to medical devices.