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ID431899
ReferenceDK431899
TitleRegulatory and Quality Manager
Job TypePermanent
LocationUnited Arab Emirates
DescriptionWe 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

Skills:
Audit technics
Redaction capacity
Animate a meeting
Animate a training
Listening skills
Methodology
Diplomacy
Confidentiality
Proposition, initiative
Decision taking
Team work
Organization
Create and follow up KPI
English oral, written
Project management
Process approach
Risk analysis
KPI

Other skills:
Orientation action
Leadership
Analytical qualities
Planification
Change management

Standards:
ISO 9001 :2008, ISO 13485 :2004
Guidelines MEDDEV

Tools:
Pack office
SAP
Regulatory watch and survey
IT regulatory software skills









Main SkillsWe 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 Skills: Audit technics Redaction capacity Animate a meeting Animate a training Listening skills Methodology Diplomacy Confidentiality Proposition, initiative Decision taking Team work Organization Create and follow up KPI English oral, written Project management Process approach Risk analysis KPI Other skills: Orientation action Leadership Analytical qualities Planification Change management Standards: ISO 9001 :2008, ISO 13485 :2004 Guidelines MEDDEV Tools: Pack office SAP Regulatory watch and survey IT regulatory software skills
IndustryHealthcare, Hospital & Medical Services
FunctionsOperations
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