Specialist, Quality & Regulatory Affairs
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 Riyadh office in Saudi Arabia, 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 competent authorities for KSA and other EMEA markets.
Provide Quality & Regulatory Affairs support for EMEA markets, in compliance with applicable regulations and standards to ensure timely commercialization of products.
Develop and execute registration strategy in close partnership with Global RA & local RA manager.
Support regional distribution control (in compliance with applicable regulations and standards) to ensure timely commercialization of products.
Review and validate regulatory data executing outbound flow.
Ensure deployment and improvement of regulatory document related to new project development.
Support as required the EMEA QRA team to ensure quality and regulatory compliance in accordance with national and European regulations.
Act as the QRA representative in regional project meeting.
Essential Functions and Responsibilities
With moderate supervision, you will be responsible for the following Regulatory and Quality activities:
Developing and implementing regulatory strategies and processes to ensure timely commercialization of products in compliance with applicable regulations and standards.
Preparing documentation to support product registration and modifications according to project phase implementation.
Overall registration strategies, coordination, implementation, execution, control and completion of product registrations in EMEA countries.
Providing Regulatory intelligence.
Supporting communication with our local agent and distributors in EMEA countries.
Acting as QRA representative in the project implementation and work activity with various stakeholders.
Notification to the regional quality and regulatory team for sharing status’ & updates of ongoing projects.
Monitoring of local Regulatory environment, new regulations and supporting feedback and gap assessments to international Regulatory departments and business partners that impact projects.
Ensuring follow-up/improvement of the distribution control procedure.
Maintaining and archiving of all regulatory documentation in the region.
Where needed, supporting the reporting of Serious Adverse Events to Competent Authority(ies) in EMEA.
Ensuring compliance with quality procedures, laws and regulations of the applicable markets.
Communicating business related issues or opportunities to next management level.
Ensuring personal and company compliance with all local and company regulations, policies, and procedures.
Training and deployment of local tools related to distribution control.
Ensuring QRA administrative tasks related to assigned projects are completed.
Perform other duties assigned as needed.
Qualifications and Experience
BA/BS in Scientific discipline or equivalent work experience (3 years min).
BS degree in Pharmacy, Medicine, Physical or Biological science or similar obtained by experience.
Minimum of 3 years’ experience in Regulatory Affairs in Saudi Arabia and MEA region.
Fluency in written and verbal English and Arabic is mandatory.
Consistent background and knowledge of SFDA regulations for Medical Devices, strong connections with SFDA will be preferred.
Must be proficient with MS Office applications.
Excellent communication skills (verbal and written).
Project management skills preferred.
Problem solving skills.
Presentation skills preferred.
High degree of initiative.
Open minded, listens to others.
Able to manage complexity within a matrix organization.
At ease in international environment.
Hands on/can do attitude.
Excellent attention to details.
Benefits
Comprehensive local medical insurance for the employee and his/her family
Various allowances
Long term disability support, etc.
The Company
Headquartered in Dublin, Ohio, Cardinal Health (NYSE: CAH) is a health care services company that improves the cost-effectiveness of healthcare. As the business behind healthcare, Cardinal Health helps pharmacies, hospitals and ambulatory care sites focus on patient care while reducing costs, improving efficiency and quality, and increasing profitability. Cardinal Health is an essential link in the healthcare supply chain, providing pharmaceuticals and medical products to more than 100,000 locations each day and is also the industry-leading direct-to-home medical supplies distributor. The company is a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company supports the growing diagnostic industry by supplying medical products to clinical laboratories and operating the nation's largest network of radio pharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #14 on the Fortune 500, Cardinal Health employs more than 50,000 people worldwide.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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