Specialist, Quality & Regulatory Affairs

at  Cardinal Health

At Cardinal Health, we aim to be a trusted partner, offering a broad range of innovative solutions that help our customers provide cost-efficient, more effective healthcare. Join our team of 50,000 humble partners striving each day to make healthcare more efficient, providers more effective, and patients as healthy as possible.

We are currently looking to recruit a Specialist Quality & Regulatory Affairs based in our Dubai office in UAE. reporting to the Quality and Regulatory Affairs Manager, you will be responsible for, but not limited to, the following:

• Ensuring accurate and timely registration of products with EMEA competent authorities.
• Provide Quality & Regulatory Affairs support for EMEA commercial teams, in compliance with applicable regulations and standards to ensure timely commercialization of products.
• Ensure quality and regulatory compliance in accordance with national and EMEA regulations.
• Review and validate regulatory data executing outbound flow.
• Act as the QRA representative in regional project meeting.

QUALIFICATIONS & EXPERIENCE

• BA/BS in Scientific discipline or equivalent work experience (2 years min).
• Desired MA/MS in Medicines, biology, pharmacy.
• 2-3 years of related experience in Regulatory Affairs or Quality Affairs in the Medical Devices area in EMEA countries.
• Consistent background and knowledge of MD regulations.
• Excellent communication skills (verbal and written);
• Project management skills preferred;
• Must be proficient with MS Office applications.
• Must be Proficient in Arabic and English.
• Interacts well with peers and colleagues worldwide, communicating and working with upper management.
• Action orientation and strong ability and willingness to learn new things quickly.
• Independent, proactive, and optimistic personality with strong problem-solving skills
• At ease in international environment.
• Attention to details.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

With moderate supervision, responsible for the following Regulatory and Quality activities:

• Define and implement regulatory strategies to be regulatory compliance with Cardinal Health products worldwide and support company growth.
• Support and advice the assigned project tasks relevant to regulatory affairs from product inception to product launch and post-market survey.
• Responsible for the overall registration strategies, coordination, implementation, execution, control and completion of product registrations in all MEA countries
• Ensure personal and company compliance with all Federal, State, local and Company regulations, policies and procedures.
• Participate in the review of Cardinal Health’s marketing material that reference products and/or disease state information to ensure the overall product compliance.
• Conduct the Regulations and Standard survey in order to interpret new regulatory requirements as they relate to company products and procedures.
• Provides solutions to a variety of problems of limited scope and complexity.
• Provide Regulatory intelligence.
• Support communication with our local agent and distributors in the countries.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for the maintenance and archiving of all regulatory documentation in the region.
• Responsible of registration of new products in assigned countries.
• Where needed, support the reporting of Serious Adverse Events to Competent Authority(ies) in EMEA.
• Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets

We are currently looking to recruit a Specialist Quality & Regulatory Affairs based in our Dubai office in UAE. reporting to the Quality and Regulatory Affairs Manager, you will be responsible for, but not limited to, the following:

• Ensuring accurate and timely registration of products with EMEA competent authorities.
• Provide Quality & Regulatory Affairs support for EMEA commercial teams, in compliance with applicable regulations and standards to ensure timely commercialization of products.
• Ensure quality and regulatory compliance in accordance with national and EMEA regulations.
• Review and validate regulatory data executing outbound flow.
• Act as the QRA representative in regional project meeting