Quality and Regulatory Affairs Lead in Dubai, United Arab Emirates

Job Description

Quality & Regulatory Affairs Lead – Health Systems, Middle East

Quality Management System

• To create Quality and Regulatory Awareness level as determined within the organization.
• Establish and implement a Simplified Quality System within the organization; establish an effective Management Review process, including routine reporting.
• Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
• Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications. Includes Complaint handling
• Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product compliant activities and processes.
• Direct the Audit Program for the organization.
• Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation.
• Monitors and tracks QMS KPIs. Helps prepare for local Management Review.
• Supports initiation of CAPAs to address process failures/ audit non-conformity and improvements.

Regulatory Affairs:

• Review development quality reports and plans to ensure that the information required for submissions is adequate
• Plan, generate, and coordinate regulatory submissions for product/solution licensing
• Coordinate testing required to support regulatory submissions (just in some countries)
• Review and approve product/solution labeling and product/solution-related marketing communications
• Maintain existing regulatory filings/ licenses, managing updates and related change control processes

Post Market Surveillance & Vigilance Reporting

• AE Reporting: Communicate MDR/MIR to the customer and Competent Authorities and or other regulatory agency as required by country/Market.
• Field Action Management: Manages recall responses, recall file documentation, recall file completion

Regulatory Intelligence gathering

• Works closely with local (and assigned geography) Competent Authorities to understand implementation of Medical Device Regulations (or any other regulations) impacting Philips Product portfolio.
• Establishes contacts within local competent authorities to support necessary regulatory activity submission.
• Participate in Industry Trade association and establishes as subject matter expert.

Supplier Quality Assurance

• Sets/updates purchasing control requirements to suppliers, classification of suppliers, and risk categorization
• Owns supplier qualification, audit, and assessment. This includes supporting and defending Philips in external and internal inspections/audits, and supporting the closure of regulatory compliance gaps at suppliers and suppler non-conformances.
• Participates in supplier selection process; maintain the Approved Supplier List (ASL) and documented evidence of evaluation records
• Actively monitors supplier quality metrics, quality agreements with critical suppliers, and quality of supplier records and drives supplier quality management review with relevant stakeholdersApplies the same for Distributor/ Partner Management program

Generic/ Personal.

• Able to work independently and set own targets on work, but also understands when escalation or support is needed.
• Able to build up a good Product Knowledge necessary to understand the requirements of the Regulatory impact
• Experience in the Regulatory Environment of the Medical Device Sector.
• Fluent English in speech and writing. Arabic speaking a plus.
• Good skills in Microsoft Office, specifically MS Excel to set-up status trackers.
• Able to build up a strong Network within Philips Community and Industry Q&R Community.
• Good communication skills.
• Able to work in a complex organizational structure
• Cooperate closely with Direct Line and Second Line Manager as well as other stakeholders in the process
• Understanding of Regulations impacting medical devices
• Understanding and experience in implementation/ deployment of ISO 9001 and ISO 13485 Quality Management Systems.
• Be hands-on.

Quality & Regulatory Affairs Lead – Health Systems, Middle East

Overview:

The position will provide leadership in driving adherence to QMS process and facilitate continuous improvement and management of Quality Management System. The position will also drive necessary product registration and approval activities for Health Systems product portfolio in Middle East. He/She will maintain the overview of registration status and be active in understanding the Regulatory landscape for Personal Health products. In the event of safety incidents/ product complaints, He/She will ensure necessary coordination with factories to ensure investigation and resolution of reported incident. In addition, the position will also serve to provide support full Q&R support to Personal Health in Middle East.

Will work with Distributor/ Partner Excellence program to ensure review and status of distributor compliance on operational process and utilize Continuous Improvement tools to drive performance & compliance improvements.

Key Responsibilities:

Quality Management System

• To create Quality and Regulatory awareness level as determined within the organization
• Establish and implement a simplified quality system within the organization; establish an effective management review process, including routine reporting
• Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction
• Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications, Includes complaint handling
• Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product compliant activities and processes
• Direct the audit program for the organization
• Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation
• Monitors and tracks QMS KPIs to helps prepare for local management review
• Supports initiation of CAPAs to address process failures/ audit non-conformity and improvements

Regulatory Affairs

• Review development quality reports and plans to ensure that the information required for submissions is adequate
• Plan, generate and coordinate regulatory submissions for product/solution licensing
• Coordinate testing required to support regulatory submissions (just in some countries)
• Review and approve product/solution labeling and product/solution-related marketing communications
• Maintain existing regulatory filings/ licenses, managing updates and related change control processes
• Post Market Surveillance & Vigilance Reporting

AE Reporting

• Communicate MDR/MIR to the customer and competent authorities and or other regulatory agency as required by country/Market
• Manages recall responses, recall file documentation, recall file completion
• Works closely with local (and assigned geography) competent authorities to understand implementation of medical device regulations (or any other regulations) impacting Philips product portfolio
• Establishes contacts within local competent authorities to support necessary regulatory activity submission
• Participate in Industry trade association and establishes as subject matter expert
• Sets/updates purchasing control requirements to suppliers, classification of suppliers, and risk categorization
• Owns supplier qualification, audit, and assessment – This includes supporting and defending Philips in external and internal inspections/audits, and supporting the closure of regulatory compliance gaps at suppliers and suppler non-conformances
• Participates in supplier selection process; maintain the Approved Supplier List (ASL) and documented evidence of evaluation records
• Actively monitors supplier quality metrics, quality agreements with critical suppliers, and quality of supplier records and drives supplier quality management review with relevant stakeholders
• Applies the same for distributor/ partner management program

Qualifications & Experience:

• Able to work independently and set own targets on work, but also understands when escalation or support is needed
• Able to build up a good Product Knowledge necessary to understand the requirements of the Regulatory impact
• Experience in the Regulatory Environment of the Medical Device Sector
• Fluent English in speech and writing. Arabic speaking a plus
• Good skills in Microsoft Office, specifically MS Excel to set-up status trackers
• Able to build up a strong Network within Philips Community and Industry Q&R Community.
• Good communication skills
• Able to work in a complex organizational structure
• Cooperate closely with Direct Line and Second Line Manager as well as other stakeholders in the process
• Understanding of Regulations impacting medical devices
• Understanding and experience in implementation/ deployment of ISO 9001 and ISO 13485 Quality Management Systems

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

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