Regulatory Affairs Manager (EMEA)
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.
- Prepare, assemble and submit regulatory submissions
- Provide input for regulatory requirements and regulatory strategies in interdepartmental meetings
- Responsible for performing all duties in compliance with ISO13485, Medical Device Directive 93/42/EEC (and all applicable amendments), Personal Protective Equipment (PPE) Directive 89/686/EEC, FDA's Quality Systems Regulations, GMP's, Canadian Medical Device Regulations; and other international regulatory requirements
- Responsible for regulatory related design and development activities
- Participate in root cause analysis, corrective and preventive actions for product and process issues
- 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 in support of product submissions and marketing collateral
- 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 required (Advanced degree is preferred)
- Regulatory Affairs Certification (International)
- 5-8 years of experience in managing Regulatory Affairs for medical devices
- Proven experience with preparation of regulatory submissions, such as CE Mark Technical Files, Summary Technical Documents, Device Design Dossiers and other international regulatory submissions in various countries within European, Middle Eastern and African (EMEA) regions
- Knowledge of FDA's Quality Systems Regulations, GMP's, ISO13485, Medical Device Directive 93/42/EEC (and all applicable amendments); European PPE Directive 89/686/EEC, ISO regulations/standards, including ISO 13485, 10993, 14971
Please apply online at: www.cardinalhealth.com/careers
Click on Apply Today and type in job number 20010326.
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.