{"id":3782313,"url":"https://alion.io/job/medline-associate-regulatory-udi-operations","title":"Associate Regulatory UDI Operations","company":{"id":7482,"name":"Medline","domain":"medline.com","url":"https://alion.io/company/medline","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":113,"ghost_share":0.018,"stale_share":0.69,"repost_share":0.044,"time_to_fill_p50_days":31,"computed_at":"2026-11-06T05:58:05Z"}},"role":"Biotech","role_family":"Biotech","seniority":"junior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Northfield, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":67000,"max":101000,"currency":"USD","period":"year","gross":null,"usd_annual":101000},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-11-04T00:00:00Z","employer_posted_date":"2026-11-04","last_verified_at":"2026-11-06T04:35:55Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Job Summary\nThis role will be responsible for supporting and executing the operational elements of the UDI program implementation and maintenance.Job Description\nMAJOR RESPONSIBILITIES:\nCollect 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\nAssist in ensuring data accuracy between labels and master UDI data, aligning with US FDA regulations and other regulations as needed\nWork 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\nAssist Regulatory Affairs members and other cross-functional teams (e.g., Supply Chain, R&D, QA, Marketing, etc.,) in implementing UDI compliant solutions\nSupport Quality Management System integration projects related to medical device labeling/ UDI compliance\nAssist 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\nAssist in compiling and reviewing documentation and procedures related to product development, manufacturing, and quality in accordance with UDI regulatory standards and internal requirements\nEffectively 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\nAssist in providing necessary training on UDI/GUDID to various groups to ensure data integrity, compliance, and understanding of the requirements.\nSupport the identification and proposal of process improvements to enhance flow and accuracy of Medline data to GUDID and other regulatory data submissions.\nMINIMUM JOB REQUIREMENTS:\nEducation:\nBachelor’s degree (life sciences preferred)\nWork Experience:\n1 year of experience in a Quality or Regulatory role for a regulated industry.\nKnowledge / Skills / Abilities:\nManufacturing Practices, or willingness to learn through training and guided research.\nDetail oriented with strong communication, organizational, analytical, and critical thinking skills.\nExperience using time management skills to prioritize, organize, and track details to meet deadlines of multiple projects.\nSelf-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.\nRelationship building and project management skills, to deliver results and meet deadlines.\nExperience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).\nPREFERRED JOB REQUIREMENTS:\nEducation:\nBachelor’s degree (life sciences preferred)\nWork Experience:\nMinimum of two (2) years of working experience and current knowledge of medical device labeling/UDI regulations, standards, and guidance\nKnowledge / Skills / Abilities:\nWork experience in evaluating information to determine compliance with standards, laws, and regulations.\nKnowledge and understanding of FDA product codes and product class structure, Quality Management Systems and Good\nManufacturing Practices, or willingness to learn through training and independent research.\nDetail oriented with strong communication, organizational, analytical, and critical thinking skills.\nExperience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.\nSelf-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.\nRelationship building and project management skills, to deliver results and meet deadlines.\nExperience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).\nMedline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.\nThe anticipated salary range for this position:\n$67,000.00 - $101,000.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.\nOur benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.\nWe’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.\nMedline Industries, LP is an equal opportunity employer. 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