Quality / Regulatory Affairs Officer

Job details

Quality / Regulatory Affairs Officer: This is an exceptional opportunity for an experienced Quality / Regulatory professional to join an exceptional Dorset based medical device manufacturing organisation. The Quality / Regulatory Officer will essentially take responsibility for driving forward the Quality Management Systems in line with medical device quality (ISO13485) and regulatory (MDD 93/42 EEC & Directive 2007/47 EC) standards. The Quality / Regulatory Affairs Officer will take an important role from the outset.

Quality / Regulatory Affairs Officer - key responsibilities:

• Initiate and support process improvement
• Preparing regulatory submissions for global product registrations (510k submissions)
• Liaising with various personnel including agencies and regulatory bodies
• Implementation of health and safety issues
• Drive forward the Quality Management Systems
• Ensure CE marked products meet EEA standards

Quality / Regulatory Affairs Officer - qualifications, skills and experience:

• Comprehensive quality assurance / regulatory affairs experience within a medical devices setting
• Solid experience within a manufacturing environment
• Exceptional communication skills (written and verbal)
• Exceptional team player and the ability to work under
• Highly organised and the ability to complete all necessary supporting documentation

Quality / Regulatory Affairs Officer: A superb career opportunity for a dedicated Quality / Regulatory professional to join a high quality Medical Devices manufacturing company.

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