What Reg Affairs Manufacturing FDA contributes to Cardinal Health

• Execute quality and regulatory processes;
• Guarantee that regulatory requirements are populated to meet local and national laws and company standards in order to place and/or maintain products;
• Support the regulatory project management and its implementation against the project plan;
• Support implementation of regulatory strategies and processes to assure timely commercialization of products according to project change.

Essential Duties and Responsibilities

• Act as project specialist in the region for rebranding project;
• Support distribution control processes in relation to rebranding project;
• Follow regulatory change project implementation;
• Maintain special requirements file and communicate country specific restrictions to local QRA;
• Regulatory documentation validation in relation to rebranding and relabeling project;
• Prepare the regulatory documentation for new rebranded item;
• Ensure coordination and consolidation of RA assessment notification for the region regarding the regulatory project change;
• Support the overall registration strategies, coordination, implementation, execution, control renewal, and completion of regulatory change project;
• Provide regulatory support to the Sales and Marketing department, Tenders department, supply chain as part of project cross functional meeting;
• Execute project management tracking and develop traceability tool to communicate and share progress with the team.

Education and Experience

• Bachelor?s Degree in Nursing, Engineering, Physical or Biological science or related field of study or related experience in the medical device industry; MS degree preferred;
• At least 2 years? experience in the medical industry and in Regulatory Affairs of Medical Devices and/or Scientific formation +/-master in Regulatory Affairs or MD;
• Background and knowledge of MD regulations;
• Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, local regulatory body Device Law/Regulations, consultant agency;
• Background on project management preferred;
• Ability to identify early the risks incurred by the company, to make the necessary warnings and propose appropriate action plans;
• Ability to work in team and to share experiences;
• Good communications skills and fluent in English;
• Strong Microsoft Excel knowledge.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.