Assoc Regulatory - UDI Ops

Job Summary

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

Affirm 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 provide regulatory input to project teams as needed

Support 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

Update and maintain procedures (SOPs) related to UDI/GUDID and other Quality documents

Collaborate with various cross-functional teams to ensure timely review, approval, and implementation of these documents

Aid in compiling and reviewing documentation and procedures related to product development, manufacturing, and quality in accordance with UDI regulatory standards and internal requirements

Communicate effectively with internal and external teams or clients regarding the status of deliverables to ensure timely and satisfactory completion of tasks and expectations

Aid in providing necessary training on UDI/GUDID to various groups to ensure data integrity, compliance, and understanding of the requirements

Aid in identifying and proposing process improvements to enhance flow and accuracy of Medline data to GUDID and other regulatory data submissions

Education

• Minimum Job Requirements: Bachelor’s degree (life sciences preferred)
• PREFERRED JOB REQUIREMENTS: Minimum of two (2) years of working experience and current knowledge of medical device labeling/UDI regulations, standards, and guidance

Knowledge/Skills/Abilities

• 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)

Pay

The Anticipated Salary Range For This Position: $67,000.00 - $101,000.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.

Benefits

• Health insurance
• Life and disability
• 401(k) contributions
• Paid time off