Regulatory Engineer- Medical Devices

2019-09-11 09:48:042019-11-05 Enterprise Recruitment
Job Type Permanent
Location Crawley
Area Sussex, England Crawley
Sector Manufacturing - Scientific
Salary £40000 - £45000 per annum
Currency GBP
Start Date ASAP
Advertiser Tom Davies
Job Ref ER12086TD1
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.

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