Regulatory Affairs Manager / Design Assurance Manager

Job details

Regulatory Affairs Manager / Design Assurance Manager
Hertfordshire / Bedfordshire / Buckinghamshire
To £45,000
Permanent

We are currently looking for a Regulatory Affairs Manager / Design Assurance Manager to join a leading medical devices company in the Home Counties area. The Regulatory Affairs Manager / Design Assurance Manager will effectively drive compliance for company products, systems and operating procedures, taking in to account all appropriate regulatory requirements.

Regulatory Affairs Manager / Design Assurance Manager - key responsibilities:

• Promote regulatory awareness throughout the business
• Regularly liaise with regulatory authorities in UK, Europe and Worldwide
• Provide regulatory and design assurance support
• Complete all necessary associated documentation
• Manage regulatory compliance
• Provide support to complaints handling and other QA teams
• RA and DA support to R&D teams in executing new product introduction (NPI) processes

Regulatory Affairs Manager / Design Assurance Manager - qualifications, skills and experience:

• Solid educational background with a degree qualification in Life Sciences or Engineering
• Comprehensive experience in a Regulatory Affairs Manager / Design Assurance Manager capacity
• Familiarity with the ISO 13485 Quality Management System
• Ability to build firm working relationships and promote and drive compliance throughout the business
• Up to date knowledge of changing international regulatory requirements and medical devices standards

This is a fantastic career opportunity for a Regulatory Affairs Manager / Design Assurance Manager to join a leading medical devices manufacturing organisation.

Apply now, send a full CV to m.norris@x4group.co.uk or call Michael on 020 7836 3942 for more information