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Quality and Regulatory Affairs Supervisor Iberia Madrid
- Ref: 2602268
- Cardinal Health
- Hace 43 horas (Actualizada)
Jornada Completa - Contrato Indefinido - Retribución sin especificar - No se requiere experiencia
* Execute quality and regulatory processes; * Guarantee improvement of the Quality Management System; * Guarantee that regulatory requirements are met in regard to local and national laws and company standards in order to place and/or maintain products on the markets; * Develop and implement regulatory strategies and processes to assure timely commercialization of products in compliance with applicable regulations and standards in country; * Act and/or supervise as Local Safety Officer for local authorities under his/her area of responsibility; * Act as business partners in supporting marketing, sales representatives, tender departments.
Duración de la oferta: hasta el 15/03/2020
* Develop and implement regulatory strategies and processes to ensure regulatory compliance of Medical Devices Products to international, regional and national laws and company standards in order to place and/or maintain products on the markets: life cycle management, notification and communication to national competent authorities * Support registration, notification and modification of products in accordance with national regulations in a timely manner; * Fully responsible for implementing PRA for the countries under his/her scope; * Responsibility of the Conformity of Promotional Material. * Copy Clearance: review and approve translations and content of advertising material as per an established process; * Provide regulatory support to the Sales and Marketing, Tenders and HCC Departments; * Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups globally to support education of local regulations; * Instill and drive a regulatory culture. Establish and support policies and standards for the measurement of new products; * Contribute to Regulatory intelligence (involvement on internal and external working group, participation to meetings and congresses); * Monitoring of local Regulatory Environment, and new regulations and support feed-back and gap assessments to International Regulatory Departments and business partners; * Responsibility of Institutional relationships (Trade associations, Competent Authority). * Ensure regulatory and quality training and assessments for Sales & Marketing Department and for any other concerned employees; * Clinical Studies application as necessary * Communicate business related issues or opportunities to next management level; * Manage subordinate staff; * 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.
* Bachelor's Degree in Nursing, Engineering, Pharmacy, Physical or Biological science or related field of study; MS degree preferred; * Five (5) to seven (7) years' experience in the medical industry with at least three to five years in Regulatory Affairs of Medical Devices; * Scientific formation +/-master in Regulatory Affairs or MD; * Consistent background and knowledge of MD regulations; * Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, local regulatory body Device Law/Regulations, World Wide Regulatory Requirements/Procedures, Project Management, and Negotiations; * Relations established with the key interlocutors in the network of the MDs (e.g., regulatory agencies, professional organizations, etc.); * Ability to identify early the risks incurred by the company, to make the necessary warnings and propose appropriate action plans, in agreement with the Quality Assurance and Regulatory Affairs Director; * Ability to work in team and to share experiences; * Excellent communications skills, including English; * Open minded, listens to others; * Customer service focused; * Able to manage complexity and Matrix organization .
Full, permanent contract. US$35000 - US$50000 per year
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