Title: Design Control and Regulatory Systems Engineer
Job Type: Full time, Permanent
Salary: £42,000 - £47,000 per annum dependent on skills and experience
Contact Person: Miss Rashida Khan
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 be based 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 £42,000 - £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.