Senior Labeling Specialist Trainer – Medical Devices Industry

3 weeks ago

Bhubaneshwar, India Tek Support Full time

Job Title: Senior Labeling Specialist Trainer – Medical Devices Industry Location: Remote Job Type: Part-time Job Summary: We are seeking an experienced Labeling Specialist Trainer with over 10 years of expertise in medical device labeling, regulatory compliance, and documentation control. The trainer will be responsible for developing and delivering comprehensive training programs that enhance the understanding of global labeling standards, systems, and processes among regulatory, quality, and manufacturing teams. The ideal candidate will have a deep understanding of medical device labeling regulations (FDA, EU MDR, ISO 15223, ISO 20417, UDI requirements) and experience in label design tools and labeling systems used in the industry. Key Responsibilities: - Design and deliver technical and compliance training programs on medical device labeling requirements, standards, and systems. - Provide hands-on training on labeling software (e.g., Prisym 360, Loftware, Bartender, NiceLabel, etc.). - Develop and update training materials, SOPs, and competency assessment tools related to labeling processes. - Ensure trainees understand regulatory and quality requirements (FDA 21 CFR Part 801, EU MDR Annex I, UDI, ISO 15223-1). - Conduct compliance workshops on 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 providing expert guidance on labeling compliance. - Evaluate trainee performance and maintain training records as per quality system requirements. - Collaborate with subject matter experts to continuously improve labeling process training content and delivery. Required Qualifications: - Bachelor’s or Master’s degree in Engineering, Life Sciences, Regulatory Affairs, or related field. - 10+ years of experience in medical device labeling operations, compliance, or artwork management. - Strong knowledge of global labeling regulations (FDA, EU MDR, CFDA, Health Canada, etc.). - Proficient in labeling tools and PLM/QMS systems (e.g., SAP, Agile, Windchill). - Experience in training and mentoring professionals in a regulated environment. - Familiarity with document control systems and CAPA processes. - Excellent communication, presentation, and documentation skills. - Certification or experience in Instructional Design / Training Delivery is a plus. Preferred Skills: - Understanding of UDI databases (e.g., GUDID, EUDAMED). - Knowledge of graphic design principles for labeling (Adobe Illustrator, InDesign basics). - Experience in label change management workflows. - Exposure to risk management (ISO 14971) and quality management systems (ISO 13485).

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