Regulatory Engineer- Medical
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Job Type | Permanent |
Location | Crawley |
Area | Sussex, England |
Sector | Manufacturing - Quality |
Salary | £50000 - £60000 per annum, Benefits: Excellent Benefits |
Currency | GBP |
Start Date | ASAP |
Advertiser | Adam Godfrey |
Job Ref | ER12086666AG |
- Description
- 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, in a range of hi-tech applications from neonatal innovation to patient warning systems. 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
- Knowledge of risk management and design validation approaches.
- An understanding of testing approaches related to medical devices.