Regulatory Engineer- Medical

Enterprise Recruitment Ltd
10 Jan 2018
09 Feb 2018
Contract Type
Full Time
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, 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.

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