Overview

SUMMARY OF POSITION:
Cardinal Health is seeking a Regulatory Affairs Specialist to support the Medical Solutions team. The selected candidate’s primary responsibility will be to provide regulatory support for transition of MDD Technical Files to compliant EU MDR Technical Documents.

• Prepare, compile and Complete EU MDR Technical Document
• Review design and manufacturing documentation for compliance with applicable regulations, product standards and policies
• Provide technical review of data or reports that will be incorporated into EU Technical Documentation to assure scientific rigor, accuracy, and clarity of presentation.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance
• Review Clinical Evaluations to assure compliance with EU MDR requirements
• Review of Post Market Surveillance Plans to assure correct data will be solicited to satisfy EU MDR requirements
• Review of Risk Management Files for compliance with ISO 14971
• Review product labeling for compliance with global labeling regulations
• Review marketing literature for compliance with regulations governing advertising and promotion

ESSENTIAL FUNCTIONS:
• Working knowledge and understanding of EU medical device regulation
• Experienced Technical Writer

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
• Ability to work in a fast-paced team environment
• High degree of initiative with the ability to work independently with minimal supervision
• Ability to prepare and present concise information to group
• Experience working effectively in a cross-functional team setting
• Ability to comprehend principles of engineering, physiology and medical device use
• Capacity to plan and organize work while remaining flexible enough to handle multiple priorities.
• Deadline conscious

MINIMUM REQUIREMENTS:
Education:
• Bachelor Degree in scientific discipline required

Experience:
• 3-5 years Regulatory Affairs experience required
• Majority of Regulatory Affairs experience in Medical Device industry preferred Tracking

To Apply: https://www.jobg8.com/Traffic.aspx?YoougGHUlIBWfdSZCmvkawn