Previous Job
Previous
Regulatory Affairs Rebranding Specialist
Ref No.: 18-62908
Location: Mansfield, Massachusetts
Position Type:Contract
Start Date: 08/29/2018
 Job Title: Regulatory Affairs Rebranding Specialist
Location: Mansfield, MA
 
Overview:
The Regulatory Affairs Rebranding Specialist will provide regulatory support throughout the rebranding of device labeling across multiple classes of trade within the Patient Recovery business
 
Primary Skills:
Product rebranding, Labeling & project Management expereince
• Participate in cross-functional teams supporting label rebranding
• Partnering with Regulatory Product Specialists, provide regulatory assessment of change on label changes
• Support the Change Development Process through planning, review, execution, and approval of label changes
• Review and approve label artwork changes for compliance with global labeling regulations and product filings
• In collaboration with International Regulatory Affairs, determine applicable registration requirements and assist in preparation of documentation to support re-registration of label changes
• Maintain regulatory systems and produce various reports as needed
• Effective project management skills
• Effective oral and written communication skills
• Effective problem-solving skills
• Ability to create cross-functional partnerships
• Ability to work collaboratively in a team environment
• Ability to apply judgment within defined parameters
• Ability to manage multiple projects
• Strong organizational skills
• Deadline conscious
 
Secondary Skills:
•Ability to perform all assigned tasks, work independently, and complete work on schedule
•Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization
•Strong problem solving skills and efficient management of time and resources
 
Educational Qualifications
BE/BS