about 1 month ago
Salary DOE + WFH Options
Bridgend / WFH
This new Regulatory Engineer 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.
You’ll work closely with Project Managers, Engineering, Operations and Quality teams to manage and coordinate risk management activities and regulatory documentation in support of new
product development, developing an understanding of the cutting edge technologies used in next generation products and playing a key role between regulatory and development teams.
This is a post with responsibility and supported autonomy and the opportunity to make a new role your own, and to develop your career in a dynamic and fast growing business overcoming a variety
of interesting challenges as you achieve regulatory approval for cutting edge products.
As Regulatory 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 Engineer will being the following experience to the team:
Experience of risk management /
regulatory activities in a highly regulated industry such as medical/pharma
Knowledge/training in ISO 14917 / ISO
The successful Regulatory Engineer will receive:
Competitive salary DOE
Working From Home
A range of working hours to select to suit your home life
25 days holiday + bank holidays
5% employer contribution pension
The opportunity to work with teams of the highest level in one of Wales’ most exciting engineering businesses!
Are you up to the challenge?
If you feel you have the skills, experience and passion to be successful in the role of Regulatory 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.