Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Patient Recovery Regulatory Affairs team. The selected candidate will provide regulatory support on a range of medical devices which include support of change development projects, change assessment, domestic submissions, international submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Patient Recovery business.
The Principal Regulatory Affairs Specialist is responsible for the support of new product development and maintenance of business projects. Specific activities include but are not limited to:
Lead the preparation, submission, and maintenance of global product registrations with a focus on U.S. 510(k)s, EU Technical Documentation aligned with new EU Medical Device Regulation and STED
Collaborate with internal Cardinal Health international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution
Review pre-clinical documentation with focus on compliance to design control
Review product labeling for compliance with global labeling regulations
Review advertising and promotional literature for compliance with applicable regulations
Interpret and evaluate proposed regulations and advise on impact of such regulations on the business
Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies
Bachelor’s Degree in a scientific discipline
5-7 years Regulatory Affairs Experience or equivalent
Majority of Regulatory Affairs experience in Medical Device industry preferred
Proficiency in US and Europe medical device regulations
Strong organizational skills
Ability to manage multiple projects
Problem solving skills
Strong oral and written communication skills
Fluent in local language required
Travel time required, up to 5%
General office environment
Internal Number: 20025559
About Cardinal Health
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company, providing customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide.
The company provides clinically-proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home. Cardinal Health connects patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by nearly 100 years of experience, with approximately 50,000 employees in nearly 60 countries, Cardinal Health ranks among the top 25 on the Fortune 500.
Cardinal Health is more than a business, more than a partner, more than hard workers. It’s wings. Its unrivaled scale and focused approach leads to better solutions. The company’s strength flows from four areas of expertise: logistics, product, business and patient solutions. Cardinal Health welcomes new challenges, anticipates trends, and as Wings, brings support, speed, and mile-high vision to all customers.