Key Responsibilities
- Gather UDI (Unique Device Identifier) data attributes from multiple sources, verifying and entering data into internal and external databases while ensuring compliance with US FDA and other relevant regulations.
- Ensure data accuracy between product labels and master UDI records, aligning with US FDA regulations and other applicable standards.
- Collaborate with cross-functional teams across multiple sites to align regulatory submission requirements with labeling and UDI database entries, providing regulatory guidance to project teams when needed.
- Assist Regulatory Affairs and cross-functional teams (e.g., Supply Chain, R&D, QA, Marketing) in implementing UDI-compliant solutions.
- Support Quality Management System (QMS) integration projects related to medical device labeling and UDI compliance.
- Help update and maintain Standard Operating Procedures (SOPs) related to UDI/GUDID and other quality documentation.
- Work collaboratively with cross-functional teams to ensure the timely review, approval, and implementation of updated procedures and documents.
- Assist in compiling and reviewing product development, manufacturing, and quality documentation to ensure compliance with UDI regulatory standards and internal requirements.
- Communicate effectively with internal and external teams, as well as clients, to provide updates on deliverables, ensuring timely and satisfactory completion of tasks.
- Provide training on UDI/GUDID requirements to various groups to ensure data integrity, regulatory compliance, and a clear understanding of the requirements.
- Support process improvement initiatives aimed at enhancing the accuracy and efficiency of data submissions to GUDID and other regulatory bodies.
Qualifications
Education
- Bachelor’s degree, preferably in life sciences.
Work Experience
- At least 1 year of experience in a Quality or Regulatory role within a regulated industry.
Knowledge, Skills, and Abilities
- Familiarity with Manufacturing Practices or a willingness to learn through training and research.
- Strong attention to detail, with excellent communication, organizational, analytical, and critical thinking abilities.
- Proven time management skills to effectively prioritize, organize, and track details for meeting multiple project deadlines.
- Self-motivated with the ability to work collaboratively in a team environment on projects of varying complexity, with some supervision.
- Strong relationship-building and project management skills to ensure timely delivery of results.
- Proficiency with MS Office Suite, including Word, Excel, PowerPoint, and Outlook.
