Senior Labeling Specialist Trainer – Medical Devices Industry

Job Title: Senior Labeling Specialist Trainer – Medical Devices Industry

Location:

Job Type:

Job Summary:

Labeling Specialist Trainer

medical device labeling regulations (FDA, EU MDR, ISO 15223, ISO 20417, UDI requirements)

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)

  .