Regulatory and Quality Manager – Manpower Middle East

We are now recruiting for a Regulatory and Quality Manager, Middle East, Africa. This position will be based in Dubai.
Missions principales :
– Animation and coordination of the quality system
– Regulatory support
– Responsible of the post market surveillance complaints
– Training
– Internal auditor
Responsible of Quality Management System implementation
Participate to processes pilot
• Support definition of MEA processes by its missions, data input, data output and the interfaces with the other processes.
• Define your means, in resources and materials for your processes.
• To control the application of the processes, operational models, processes forms to which the process is attached.
• To control the follow up and the updates of the indicators on a monthly basis.
• To analyze the results and propose the improvements axis.
• Every year propose improvements to the processes; update the procedures, the operational models, the quality forms in the scope of the activity.
• Participate to the pilot committee every 2 months.
• Participate to the processes review every year
• Participate to the tri-monthly review.
Apply the complaints procedures and customers follow up for company’s group portfolio
• Evaluate patient risks, end users risks
• To collect necessary information and recover the devices incriminated for expertise
• Realize the link with the sales team and communicate to Business Area
• Realize the link with the field and communicate information to customer
• Translate and understand the technical documentation to support the submissions
• Elaborate and follow post market surveillance
• Update the Masterfile follow up for each business area
• Support translations to customers
• Coordinate actions on recalls and Field Safety Corrective Action
• Maintain the files associated to it
• Animate the meetings with the 3 commercial divisions
Internal auditor
• Animate internal auditors meetings
• Plan audits
• Realize and send audit plan to management team
• Prepare and animate audit plan
• Write audit report
• Animate closure meeting
• Prepare and participate to external audit
Regulatory support Middle East and Africa
Analyze and solve regulatory issues met by the sales team
Participate to the regulatory watch and survey
Support quality and regulatory projects – provide Gantt charts or other …
Develop and ensure quality and regulatory communication and sensitization to QRC concepts:
– Create and spread practical brochures
– Communicate the regulatory and quality documents, regulatory watch and survey
– Support the development of a center of excellence

Job Details

Date Posted: 2017-09-17
Job Location: Dubai, United Arab Emirates
Job Role: Management
Company Industry: Employment Placement Agencies/Recruiting

Preferred Candidate

Career Level: Management

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