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Specialist, Regulatory and Quality Affairs Madrid
- Ref: 2543448
- Cardinal Health
- Hace 43 horas (Actualizada)
Jornada Completa - Contrato Indefinido - Retribución sin especificar - No se requiere experiencia
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. More information about the company may be found at www.cardinalhealth.com
Duración de la oferta: hasta el 19/10/2019
We are currently looking to recruit a Specialist Regulatory & Quality Affairs based in our office in Madrid, Spain, and reporting to the Quality and Regulatory Affairs, Manager, you will be responsible for, but not limited to, the following. Essential Functions and Responsibilities * With moderate supervision, responsible for the following Regulatory and Quality activities: * Develop and implement regulatory strategies and processes to ensure timely commercialization of products in compliance with applicable regulations and standards Prepare documentation to support product registration and modifications * Notification to Competent Authority of New Devices placed on the Market and its modifications and Clinical Trials * Review of translation for IFU, promotional documents, Internet site….as necessary * Monitoring of local Regulatory Environment, and new regulations and support feed-back and gap assessments to International Regulatory Departments and business partners * Responsibility of the Conformity of Promotional Material in regards to company requirements and local Regulation * Training, Managing and follow up of Complaints * Ensure follow-up/improvement of the Business Management System and support ISO 13845:2016 Certification Process * Ensure development of departmental SOPs, manage internal and external audit plan, develop and manage dashboard * Implement and follow-up Corrective and Preventive Actions * Communicate business related issues or opportunities to next management level * Ensure personal and Company compliance with all local and Company regulations, policies, and procedures * Responsible of the training and deployment of local tools * Ensure administrative tasks are completed * Perform other duties assigned as needed Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Qualifications & experience * BS degree in Engineering, Physical or Biological science; * Minimum of 4 - 6 years' experience in Regulatory/Quality; * Must be familiar with MS Office applications; * Excellent communication skills (verbal and written); * Project management skills; * Problem solving skills; * Presentation skills; * High degree of initiative; * Open minded, listens to others; * Customer service focused; * Able to manage complexity and Matrix organization; * At ease in International environment; * Fluent in English and preferred languages: Spanish/Portuguese.
Our offer * Attractive compensation package including base pay, bonus and merit increases; * Retirement benefits; * High quality onboarding program; * Employee assistance program; * Partly reimbursement of annual gym fees, up to € 400,-; * Various insurance programs and much more.€30.000 - €40.000 per year
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