Regulatory & Technical File Management Engineer

Job Location	Llandarcy
Education	Not Mentioned
Salary	Salary negotiable
Industry	Not Mentioned
Functional Area	Not Mentioned
Job Type	Permanent, full-time

Job Description

Regulatory & Technical File Management Engineer SwanseaThis new post has been created with a rapidly growing engineering and manufacturing business that dominates a high growth market and is continuing to invest in all areas of the business to further press its competitive edge. The business has continued to thrive throughout 2020, securing additional state of the art facilities in South Wales and international expansion is imminent.The Regulatory & Technical File Management Engineer role will work closely with Project Managers and Engineering, Operations and Quality teams to manage and coordinate risk management activities and regulatory documentation in support of the NPD process and in line with the company’s quality system. You’ll develop an understanding of the cutting edge technologies used in next generation products and play a key role between regulatory and development in a role requiring diligence, a methodical approach, attention to detail and an ability to understand the highly technical.This is an opportunity to make a new role your own, to develop your career in a dynamic and fast growing business and to overcome interesting intellectual challenges as you achieve regulatory approval for cutting edge products.As Regulatory & Technical File Management Engineer this is what you’ll be doing:

Running the risk management program for new and current devices to IEC 14971

Creating and maintaining Risk Management documentation

Collating project files / design history and documentation for multiple projects.

Producing usability documentation

Ensuring design history documentation is ready for audits

Writing risk management procedures

Co-ordinating regulatory submissions and testing

Liaising with external approval suppliers

Creating in-country license documentation for regulatory submission

Preparing samples and related documentation for regulatory submission

Collating information from various departments for regulatory submission

The successful Regulatory & Technical File Management Engineer will being the following experience to the team:EssentialExperience of risk management activities in a regulated industry - medical, pharma, automotive, aerospaceA degree or equivalent in a technical subjectDesirableKnowledge/training in ISO 14917 / ISO 13485The successful Regulatory & Technical File Management Engineer will receive: Competitive salary DOEA range of working hours to select from to suit your home life25 days holiday + bank holidays5% employer contribution pensionFree parkingThe opportunity to work with teams of the highest level in one of Wales’ most exciting engineering businesses!Are you up to the challengeIf you feel you have the skills, experience and passion to be successful in the role of Regulatory & Technical File Management Engineer apply now.*Please note, whilst we do our best to contact all candidates, due to the high number of applications we receive we cannot guarantee this for every role. If you have not heard anything from us within 7 days of applying - then unfortunately you have been unsuccessful. Please keep an eye on our website for more opportunities.

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