Specialist, Quality & Regulatory Affairs

Cardinal Health, Inc.; Riyadh; On-site; SAR 75,000 - 120,000; Full time

Job summary

A global healthcare solutions provider seeks a Specialist in Quality & Regulatory Affairs based in Riyadh, Saudi Arabia. This role involves ensuring compliance with KSA and EMEA regulations, developing registration strategies, and supporting product commercialization. Candidates should have a BA/BS in a scientific field, at least three years of relevant experience in Regulatory Affairs, and fluency in English and Arabic.

Benefits

Comprehensive medical insurance for employee and family

Various allowances and long-term disability support

Qualifications

• Minimum 3 years of experience in Regulatory Affairs in Saudi Arabia and MEA region.
• Fluent in English and Arabic, both written and verbal.
• Knowledge of SFDA regulations for Medical Devices preferred.

Responsibilities

• Ensure accurate and timely registration of products with authorities in KSA and EMEA.
• Develop and implement regulatory strategies for product commercialization.
• Monitor local regulatory environments and provide feedback on new regulations.

Skills

Project Management

Communication

Problem Solving

Presentation Skills

Detail-oriented

Education

BA/BS in a scientific discipline or equivalent

Degree in Pharmacy, Medicine, or Biological sciences

Tools

MS Office

Job description

Specialist, Quality & Regulatory Affairs

At Cardinal Health, we aim to be a trusted partner, offering a broad range of innovative solutions to help our customers provide cost-efficient, effective healthcare. Join our team of 50,000 partners striving daily to improve healthcare efficiency, support providers, and promote patient health.

We are recruiting a Specialist, Quality & Regulatory Affairs based in Riyadh, Saudi Arabia. Reporting to the Quality and Regulatory Affairs Manager, your responsibilities include:

• Ensuring accurate and timely registration of products with authorities in KSA and other EMEA markets.
• Providing support for Quality & Regulatory Affairs in compliance with applicable regulations to facilitate product commercialization.
• Developing and executing registration strategies in collaboration with Global and local RA managers.
• Supporting regional distribution control to ensure compliance and timely product release.
• Reviewing and validating regulatory data for outbound flow.
• Managing regulatory documentation for new projects.
• Supporting the EMEA QRA team to ensure compliance with national and European regulations.
• Representing QRA in regional project meetings.

Essential Functions and Responsibilities

Under moderate supervision, you will:

• Develop and implement regulatory strategies for product commercialization.
• Prepare documentation for product registration and modifications.
• Coordinate registration activities across EMEA countries.
• Provide regulatory intelligence and support communication with local agents and distributors.
• Act as the QRA representative in project activities.
• Monitor local regulatory environments and provide feedback on new regulations.

Additional responsibilities include:

• Follow-up and improve distribution control procedures.
• Maintain and archive regulatory documentation.
• Support reporting of Serious Adverse Events to authorities.
• Ensure compliance with applicable laws and regulations.
• Communicate issues and opportunities to management.
• Ensure personal and company compliance with policies.
• Train and deploy tools related to distribution control.
• Complete QRA administrative tasks and perform other duties as assigned.

Qualifications and Experience

• BA/BS in a scientific discipline or equivalent experience (minimum 3 years).
• Degree in Pharmacy, Medicine, or Biological sciences preferred.
• At least 3 years’ experience in Regulatory Affairs in Saudi Arabia and MEA region.
• Fluent in English and Arabic, both written and verbal.
• Knowledge of SFDA regulations for Medical Devices and strong connections with SFDA are preferred.
• Proficient with MS Office.
• Excellent communication, project management, problem-solving, and presentation skills.
• Proactive, detail-oriented, and able to manage complexity within a matrix organization.
• Comfortable in an international environment with a hands-on attitude.

Benefits

• Comprehensive medical insurance for employee and family.
• Various allowances and long-term disability support.

The Company

Headquartered in Dublin, Ohio, Cardinal Health is a healthcare services company that improves healthcare cost-effectiveness. We support pharmacies, hospitals, and care sites, providing pharmaceuticals and medical products daily to over 100,000 locations. Ranked #14 on the Fortune 500, we employ over 50,000 people worldwide.

We encourage applications from back-to-work individuals, people with disabilities, veterans, and those without a college degree.

Cardinal Health values diversity and is an Equal Opportunity/Affirmative Action employer. All qualified applicants will be considered without regard to race, religion, or other protected statuses.