Quality Manager / Regulatory Affairs Manager/ Quality and Regulatory Affairs Manager

Job details

Quality Manager / Regulatory Affairs Manager/ Quality and Regulatory Affairs Manager - We are looking to speak with an exceptional Quality Manager / Regulatory Affairs Manager/ Quality and Regulatory Affairs Manager to join this leading medical devices services company. The Quality Manager / Regulatory Affairs Manager/ Quality and Regulatory Affairs Manager will be joining at a critical time, taking responsibility for developing, implementing and maintaining the company quality management system, ensuring accordance with regulatory requirements.

Quality Manager / Regulatory Affairs Manager/ Quality and Regulatory Affairs Manager - key duties:

• Develop, implement and maintain the quality management system, ensuring compliance with regulatory requirements (MDD 93/42/EEC, ISO13485:2003 and ISO9001:2008)
• Manage the internal audit programme
• Liaise with all necessary notified bodies
• Analyse data and process performance
• Produce all necessary technical documentation and analysis
• Advise and train personnel on aspects of quality / regulatory affairs
• - Liaise with all key suppliers

Quality Manager / Regulatory Affairs Manager/ Quality and Regulatory Affairs Manager

• Experience as a lead auditor - preferably ISO 13485:2003 and ISO9001:2008
• In depth knowledge of the Medical Devices Directive , ISO 9001 and ISO 13485
• Exceptional communication and interpersonal skills
• Solid educational background including a degree qualification in an engineering / quality subject
• Experience of creating and maintaining quality systems
• Previous experience of auditing suppliers

This is a fantastic opportunity Quality Manager / Regulatory Affairs Manager/ Quality and Regulatory Affairs Manager to join a leading organisation.

Apply now, send a full CV to p.rabey@x4group.co.uk or call Peter on 020 7836 3942 for more information.