Quality and Regulatory Affairs Supervisor Iberia Madrid

Descripción de la oferta

Duración de la oferta: hasta el 15/03/2020.

Funciones

 * 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.

Requisitos

 * 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 .

Se ofrece

Full, permanent contract. US$35000 - US$50000 per year