Design Control and Regulatory Systems Engineer

Design Control and Regulatory Systems Engineer - Walsall

Opportunity:

Do you have experience in design control and risk management for medical device products? Have you created Design History Files and Technical Files for medical devices? Have you created documentation for submission to FDA for 510(K) approvals? Want to work for an innovative medical device manufacturing company? If yes then this is the role for you.

Your role as a Design Control and Regulatory Systems Engineer will bebased working on site at Walsall supporting the R&D team on design controls, risk management and ensuring the medical device product development activities are in compliance with Quality and Regulatory standards.

Key responsibilities and duties include:

• Working with the R&D team to identify the work products required based on the product scope (NPI and Design Change).
• Guiding the R&D team and creating the required work products (process and product) ensuring compliance to QMS.
• Creating and maintaining the Design History Files for medical device products.
• Working with the team on work products required for 60601 testing.
• Creating documentation for submission to FDA for 510(K) approvals.
• Creating and updating product technical files in compliance with EU and relevant countries regulatory requirements.

This is a full time permanent job opportunity based in Walsall paying an excellent salary of £40,000 - £47,000 per annum and great benefits such as 23 days holidays plus bank holidays on top, Insights Bonus scheme, cycle to work scheme, Life insurance and much more.

Skills:

To apply for the role of Design Control and Regulatory Systems Engineer you will have the following:

• Bachelor’s Degree in Scientific or Engineering discipline.
• Experience in quality engineering and regulatory affairs in a medical device industry.
• Working knowledge of Medical Products Quality Management System.
• Experience in creating documentation for regulatory compliance (for example: FDA, ISO, CE, etc).
• Experience with design reviews and design controls.
• Working knowledge of CE certification requirements and transition from EU MDD to EU MDR.

How to Apply:

To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat. Please ensure you have read and agree to our Privacy Policy which can be found on the Quality Start website.

If this sounds like the role for you or a colleague then please don’t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information.

For a list of our current vacancies, please visit www.qualitystart.co.uk

If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.

Quality Start are acting as a specialist recruitment consultancy for this role.