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Regulatory Engineer- Medical Devices

Employer
Enterprise Recruitment Ltd
Location
Crawley
Salary
£40000 - £45000/annum
Closing date
4 Dec 2019

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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, 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 -          Experience working with IEC 60601, IES 62304 -          Knowledge of risk management and design validation approaches.  -          An understanding of testing approaches related to medical devices

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