Senior Medical Device Labeling Lead & Technical Writer

Lancesoft; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Lancesoft in Irvine, CA seeks a seasoned professional to lead the development and lifecycle management of customer-facing medical device labeling content and artwork. You will translate complex regulatory and technical information into clear, accurate content for healthcare professionals, clinicians, and patients.

Responsibilities include end-to-end labeling development using InDesign/Illustrator, content strategy, and ensuring compliance with FDA, EU MDR, and ISO standards while partnering with

Qualifications

• Advanced degree with 5+ years of relevant experience, or a University Degree with 7+ years of relevant experience.
• Medical devices labeling experience and proficiency with IFU content creation and artwork development.

Responsibilities

• Lead end-to-end labeling development for IFUs, user guides, electronic labeling, and packaging artwork.
• Translate complex regulatory and technical information into clear, user-focused content for healthcare professionals and patients.
• Ensure labeling content complies with FDA, EU MDR, IMDRF, UDI, IEC60601, ISO20417, ISO15223, and internal standards.
• Collaborate with R&D, Regulatory, Quality, Marketing, and Clinical teams to meet milestones.
• Manage change orders, design control deliverables, and ensure traceability and verification.

Skills

Technical writing

Regulatory knowledge

Cross-functional leadership

Labeling development

Risk management

Education

Advanced degree or equivalent experience

MS/BS in related field

Tools

Adobe InDesign

Adobe Illustrator

CMS tools

Job description

Lancesoft in Irvine, CA seeks a seasoned professional to lead the development and lifecycle management of customer-facing medical device labeling content and artwork. You will translate complex regulatory and technical information into clear, accurate content for healthcare professionals, clinicians, and patients.

Responsibilities include end-to-end labeling development using InDesign/Illustrator, content strategy, and ensuring compliance with FDA, EU MDR, and ISO standards while partnering with