Senior Labeling Specialist Trainer – Medical Devices Industry

24 hours ago


New Delhi, India Tek Support Full time

Job Title: Senior Labeling Specialist Trainer – Medical Devices Industry Location:Remote Job Type:Part-timeJob Summary: We are seeking an experiencedLabeling Specialist Trainerwith over10 years of expertise in medical device labeling, regulatory compliance, and documentation control . The trainer will be responsible fordeveloping and delivering comprehensive training programsthat enhance the understanding of global labeling standards, systems, and processes among regulatory, quality, and manufacturing teams. The ideal candidate will have a deep understanding ofmedical device labeling regulations (FDA, EU MDR, ISO 15223, ISO 20417, UDI requirements)and experience inlabel design tools and labeling systemsused in the industry.Key Responsibilities: Design and delivertechnical and compliance training programson medical device labeling requirements, standards, and systems. Providehands-on trainingon labeling software (e.g., Prisym 360, Loftware, Bartender, NiceLabel, etc.). Develop and updatetraining materials , SOPs, and competency assessment tools related to labeling processes. Ensure trainees understandregulatory and quality requirements(FDA 21 CFR Part 801, EU MDR Annex I, UDI, ISO 15223-1). Conductcompliance workshopson global labeling standards, symbols, and risk-based labeling requirements. Train cross-functional teams (Regulatory Affairs, QA/RA, Manufacturing, Packaging, IT) on labeling workflows and change management. Support audits and internal assessments by providingexpert guidanceon labeling compliance. Evaluate trainee performance and maintaintraining recordsas per quality system requirements. Collaborate with subject matter experts tocontinuously improvelabeling process training content and delivery.Required Qualifications: Bachelor’s or Master’s degree inEngineering, Life Sciences, Regulatory Affairs, or related field . 10+ years of experienceinmedical device labeling operations , compliance, or artwork management. Strong knowledge ofglobal labeling regulations(FDA, EU MDR, CFDA, Health Canada, etc.). Proficient inlabeling tools and PLM/QMS systems(e.g., SAP, Agile, Windchill). Experience intraining and mentoring professionalsin a regulated environment. Familiarity withdocument control systemsand CAPA processes. Excellentcommunication, presentation, and documentation skills . Certification or experience inInstructional Design / Training Deliveryis a plus.Preferred Skills: Understanding ofUDI databases(e.g., GUDID, EUDAMED). Knowledge ofgraphic design principlesfor labeling (Adobe Illustrator, InDesign basics). Experience inlabel change management workflows . Exposure torisk management (ISO 14971)andquality management systems (ISO 13485) .



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