Regulatory Engineer- Medical

Recruiter
Enterprise Recruitment Ltd
Location
Crawley
Salary
£50000 - £60000 per annum, Benefits Excellent Benefits
Posted
04 Dec 2017
Closes
08 Dec 2017
Sector
Engineering
Contract Type
Permanent
Hours
Full Time
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.



This job was originally posted as www.totaljobs.com/job/77723635