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.
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 Healths 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
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.
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, providingpharmaceuticals 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 peopleworldwide. More information about the company may be found at www.cardinalhealth.com "" 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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