Cardinal Health Supervisor Regulatory & Quality Iberia in Madrid, Spain

At Cardinal Health, we're developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.

For our EMEA QRA Team we are looking to recruit aSpecialist Regulatory & Quality Affairs. Reporting to the Regulatory and Quality Manager Italy and Iberia your will be responsible for the following activities:

Develop regulatory submissions and assessments (in compliance with applicable regulations and standards) to ensure timely commercialization of products.

Ensure deployment and improvement of the Business Management System

Ensure quality and regulatory compliance in accordance with national and European regulations

Act as business partners in supporting marketing, sales representatives, tenders departments as requested

Act as the company QRA representative in external meeting

Essential Duties 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 – for example: Repertorio
  • 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
  • Responsibility of Institutional relationships (Trade associations, Competent Authority …..)
  • 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
  • Key contact for the Certification Body
  • 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

Requirements

  • BS degree in Engineering, Physical or Biological science + a 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
  • RAC/IRCA Certification
  • 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 Italian
  • Travel: 10%
  • Occasional weekend/travel work may be required as necessary

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.

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.