Regulatory Affairs jobs in United Kingdom

CK Group are recruiting for a Human Factors Quality Engineer to join a company in the pharmaceutical industry on a contract basis for 12 months. This is a hybrid role with 50% onsite in Cambridge.

Salary: Up to £25.98 per hour PAYE or up to £29.12 per hour via umbrella company.

• Lead design control and risk management activities for combination product development programs
• Support effective risk management activities at external design companies and manufacturing facilities
• Ensure combination product development activities are compliant with all required standards
• Support the generation of all regulatory submission data

• Hold a relevant scientific degree or have equivalent working experience
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation
• Experience in design controls and risk management for combination products
• Familiar with Human Factors Engineering – Usability Engineering
• Familiar with device assembling manufacturing processes
• Understand Good Manufacturing Practices (GMP)

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

For more information, or to apply for this Human Factors Quality Engineer please contact the Key Accounts Team on (phone number removed) or email (url removed). Please quote reference (Apply online only).

It is essential that applicants hold entitlement to work in the UK. Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.

£25.98 – £29.12/hour