Regulatory Affairs Manager (Latin America Regions/Bilingual Spanish)
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $103 billion healthcare services company that improves the cost-effectiveness of healthcare. As the business behind healthcare, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers, clinical laboratories and physician offices focus on patient care while reducing costs, enhancing efficiency and improving quality.
The Regulatory Affairs Manager (LatAm) will be responsible for managing regulatory affairs for Latin American region, including but not limited to Brazil, Mexico, Colombia, Chile, Argentina, Panama, and more.
- Prepare, assemble and submit regulatory submissions
- Provide input for regulatory requirements and regulatory strategies
- Perform all duties in compliance with ISO13485, EU Directives FDA's Quality Systems Regulations and GMP's
- Responsible for regulatory related design and development activities
- Participate in root cause analysis, corrective and preventive actions
- Maintain regulatory affairs documents and systems
- Evaluate changes to controlled documents for impact on submissions and filing requirements
- Provide input on and review of protocols and reports for: design verification and validation for material, process and facilities changes, assay/method validation, shelf life, clinical and non-clinical studies, material qualification and safety testing
- Determine governmental regulations affecting Company processes and assure the processes are complete and accurate
- Act as liaison for Company with regulatory agencies, as well as with other internal functional departments for new product submission strategy
- Review technical publications, articles, and abstracts
- Bachelor’s Degree in a scientific discipline or a related field (Advanced degree is preferred)
- 5-8 years of experience in managing Regulatory Affairs for medical devices
- Proven experience with preparation of regulatory submissions and demonstrated track record of successful regulatory approvals
- Proven experience with new product development, design controls, and quality management system
- Demonstrated track record of successful negotiations with Global regulatory agencies
- Knowledge of FDA's Quality Systems Regulations, GMP's, ISO13485 and other ISO regulations/standards, including 10993, 14971 is necessary
- Expertise in technical and operational aspects of regulatory affairs, combined with scientific understanding and strong project management
- High level of understanding of Drug, Biologics and Combination products regulations is a plus
- Proven Regulatory Affairs Certification (International) is preferred
Please apply online at: www.cardinalhealth.com/careers
Click on Apply Today and type in job number 20011994.
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.