Cardinal Health Quality and Regulatory Affairs Specialist - PORTUGAL in Madrid, Spain

SUMMARY OF THE JOB:

Retrieve and prepare documentation to support product registration and modifications to local authorities in compliance with applicable regulations and standards

Support improvements of the Quality Management System and ISO 13845 Certification Process

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

ESSENTIAL DUTIES AND RESPONSIBILITIES:

With moderate supervision, responsible for the following Regulatory and Quality activities:

  • Retrieve and prepare documentation to support product registration and modifications to local authorities in compliance with applicable regulations and standards
  • Cross-functionally work with subject matter experts within organization
  • Review of translation for IFU, promotional documents, Internet site as necessary
  • Training, Managing and follow up of Complaints
  • Support improvements of the Quality Management System and ISO 13845 Certification Process if applicable
  • Ensure administrative tasks are completed
  • Perform other duties assigned as needed

  • Responsible for communicating business related issues or opportunities to next management level

  • For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
  • Performs other duties assigned as needed

EDUCATION/TRAINING and/or EXPERIENCE:

  • BS degree in Engineering, Physical or Biological science +, 2-3 years of experience in Regulatory/Quality in Medical Device or Pharma company
  • Knowledge of local regulations for medical devices

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

  • Must be familiar with MS Office applications
  • Good communication skills (verbal and written)
  • Problem solving 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 Portuguese (Spanish is a plus)

ADDITIONAL POSITION REQUIREMENTS

  • 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.