Global Regulatory Labeling & Documentation Specialist

SprintRay Inc.; Huntington Beach (CA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

SprintRay, a Huntington Beach, CA-based company, seeks a Regulatory Labeling and Documentation Specialist to ensure medical devices meet US, EU, and MDSAP requirements. You will manage labels, IFUs, UDI data, and related QMS documentation in a fast-growing environment.

Work with R&D, QA/RA, and external vendors to translate risk assessments into compliant labeling, coordinate translations, and support regulatory submissions and audits.

Qualifications

• Bachelor’s degree in life sciences, engineering, regulatory affairs, or related field.
• 3–5 years in medical device labeling/IFU authoring or management.
• Experience with US FDA labeling, EU MDR, and at least one other MDSAP jurisdiction.
• Familiarity with ISO 13485 QMS document control and change control.
• Strong technical writing and cross-functional collaboration skills.

Responsibilities

• Prepare and maintain medical device labels, IFUs, and UDI data.
• Translate inputs and risk outputs into clear warnings and contraindications.
• Coordinate translations and verify labeling across markets.
• Manage eIFU content and website postings per regulatory requirements.
• Support QMS document routing, review, and training tracking.
• Ensure labeling compliance across markets and regulatory submissions.
• Assist with CAPAs, audits, and Notified Body interactions.
• Collaborate with R&D, Marketing, Operations, and suppliers.

Skills

Attention to detail

Regulatory writing

Cross-functional collaboration

Education

Bachelor’s degree in life sciences, engineering, regulatory affairs, or related field

Tools

ISO 13485 QMS

GUDID / EUDAMED data systems

Job description

SprintRay, a Huntington Beach, CA-based company, seeks a Regulatory Labeling and Documentation Specialist to ensure medical devices meet US, EU, and MDSAP requirements. You will manage labels, IFUs, UDI data, and related QMS documentation in a fast-growing environment.

Work with R&D, QA/RA, and external vendors to translate risk assessments into compliant labeling, coordinate translations, and support regulatory submissions and audits.