Medical Device Labeling Engineer – Regulatory & Documentation

Merit Medical; Tijuana; On-site; MXN 520,000 - 760,000; Full time

Job summary

Merit Medical seeks an experienced Labeling Engineer to support labeling development, regulatory compliance, and documentation for our medical devices. The role demands collaboration across functions and strong knowledge of global labeling standards.

The candidate should have 5+ years in labeling, familiarity with FDA/ISO 13485, and bilingual English–Spanish communication skills. This on-site position in Mexico offers exposure to multiple regulatory regimes and cross-border projects.

Qualifications

• 5 years or more of experience in labeling, regulatory, quality or manufacturing engineering.
• 3–5+ years of labeling/document control/regulatory experience.
• Experience with IFUs, UDI, packaging artwork and ECO processes.

Responsibilities

• Evaluate, select and apply standard labeling techniques and comply with regulatory criteria.
• Collaborate cross-functionally to support labeling development and documentation.
• Write ECNs and create prototypes under broad direction; may supervise technicians.

Skills

Labeling engineering

Regulatory compliance

Document control

FDA/ISO knowledge

Bilingual English–Spanish

Education

Bachelor's degree in Engineering

Tools

NiceLabel

Oracle ERP

Job description

Merit Medical seeks an experienced Labeling Engineer to support labeling development, regulatory compliance, and documentation for our medical devices. The role demands collaboration across functions and strong knowledge of global labeling standards.

The candidate should have 5+ years in labeling, familiarity with FDA/ISO 13485, and bilingual English–Spanish communication skills. This on-site position in Mexico offers exposure to multiple regulatory regimes and cross-border projects.