Assoc Regulatory - UDI Ops

Medline • Northfield, MN

3d

About The Position

This role will be responsible for supporting and executing the operational elements of the UDI program implementation and maintenance. Major Responsibilities: Collect UDI data attributes from various sources; verify and enter UDI data into internal/external databases ensuring compliance with US FDA regulations and other regulations as needed Assist in ensuring data accuracy between labels and master UDI data, aligning with US FDA regulations and other regulations as needed Work closely with cross-functional teams located at multiple sites to support alignment between required information for regulatory submissions and labeling & UDI database entries, and providing regulatory input to project teams as needed Assist Regulatory Affairs members and other cross-functional teams (e.g., Supply Chain, R&D, QA, Marketing, etc.,) in implementing UDI compliant solutions Support Quality Management System integration projects related to medical device labeling/ UDI compliance Assist in updating and maintaining procedures (SOPs) related to UDI/GUDID and other Quality documents Work collaboratively with various cross-functional teams to ensure timely review, approval, and implementation of these documents Assist in compiling and reviewing documentation and procedures related to product development, manufacturing, and quality in accordance with UDI regulatory standards and internal requirements Effectively communicate with internal and external teams and/or clients as to the status of deliverables to ensure timely and satisfactory completion of tasks and expectations Assist in providing necessary training on UDI/GUDID to various groups to ensure data integrity, compliance, and understanding of the requirements. Support the identification and proposal of process improvements to enhance flow and accuracy of Medline data to GUDID and other regulatory data submissions.

Requirements

• Bachelor’s degree (life sciences preferred)
• 1 year of experience in a Quality or Regulatory role for a regulated industry.
• Manufacturing Practices, or willingness to learn through training and guided research.
• Detail oriented with strong communication, organizational, analytical, and critical thinking skills.
• Experience using time management skills to prioritize, organize, and track details to meet deadlines of multiple projects.
• Self-starter with ability to work in team environment on projects of diverse scope where analysis of a situation or data requires evaluation of various factors with some supervision.
• Relationship building and project management skills, to deliver results and meet deadlines.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).

Nice To Haves

• Minimum of two (2) years of working experience and current knowledge of medical device labeling/UDI regulations, standards, and guidance
• Work experience in evaluating information to determine compliance with standards, laws, and regulations.
• Knowledge and understanding of FDA product codes and product class structure, Quality Management Systems and Good Manufacturing Practices, or willingness to learn through training and independent research.
• Detail oriented with strong communication, organizational, analytical, and critical thinking skills.
• Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
• Self-starter with ability to work in team environment on projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision.
• Relationship building and project management skills, to deliver results and meet deadlines.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).

Responsibilities

• Collect UDI data attributes from various sources; verify and enter UDI data into internal/external databases ensuring compliance with US FDA regulations and other regulations as needed
• Assist in ensuring data accuracy between labels and master UDI data, aligning with US FDA regulations and other regulations as needed
• Work closely with cross-functional teams located at multiple sites to support alignment between required information for regulatory submissions and labeling & UDI database entries, and providing regulatory input to project teams as needed
• Assist Regulatory Affairs members and other cross-functional teams (e.g., Supply Chain, R&D, QA, Marketing, etc.,) in implementing UDI compliant solutions
• Support Quality Management System integration projects related to medical device labeling/ UDI compliance
• Assist in updating and maintaining procedures (SOPs) related to UDI/GUDID and other Quality documents
• Work collaboratively with various cross-functional teams to ensure timely review, approval, and implementation of these documents
• Assist in compiling and reviewing documentation and procedures related to product development, manufacturing, and quality in accordance with UDI regulatory standards and internal requirements
• Effectively communicate with internal and external teams and/or clients as to the status of deliverables to ensure timely and satisfactory completion of tasks and expectations
• Assist in providing necessary training on UDI/GUDID to various groups to ensure data integrity, compliance, and understanding of the requirements.
• Support the identification and proposal of process improvements to enhance flow and accuracy of Medline data to GUDID and other regulatory data submissions.

Benefits

• health insurance
• life and disability
• 401(k) contributions
• paid time off
• Employee Assistance Program
• Employee Resource Groups
• Employee Service Corp

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level