Global Medical Device Labelling Strategist

Spectraforce Technologies, Inc.; Santa Clara (CA); Presencial; USD 100.000 - 140.000; Jornada completa

Descripción de la vacante

Spectraforce Technologies, Inc. seeks a Regulatory Affairs Labelling Specialist in Santa Clara, CA for a 12-month assignment.

You will design and implement international addendum labeling (IFUs, country labels) for medical devices, coordinating with global RA teams and US product owners. Responsibilities include developing labeling strategies, ensuring compliance with FDA and international requirements, managing large-scale labeling changes, and maintaining documentation for audits and KPI

Formación

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or related field.
• Minimum 4 years in a regulated industry with labeling/ QA/document control experience.
• Experience with labeling design and development from a regulatory perspective.
• Strong knowledge of medical device labeling regulatory requirements.
• Proficient in SAP MD and other relevant software systems.
• Excellent communication and collaboration skills.
• Detail-oriented with strong organizational skills.

Responsabilidades

• Lead centralization of post-approval addendum labeling for vascular portfolio.
• Design and develop addendum labeling (IFUs, labels, import labels, country labeling).
• Ensure labeling compliance with international/regulatory standards.
• Coordinate with international RA, US RA, PLPM, and labeling teams.
• Manage large-scale labeling change projects and timelines.
• Prepare SAP UAL package and submit labeling packages.
• Track labeling changes and provide documentation for audits.
• Monitor regulatory changes affecting labeling and update procedures.

Conocimientos

Communication

Collaboration

Detail-oriented

Time management

Problem solving

Educación

Bachelor's degree in Regulatory Affairs / Biomedical Engineering

Herramientas

SAP MD

Microsoft Office

Adobe Acrobat Pro

Descripción del empleo

Spectraforce Technologies, Inc. seeks a Regulatory Affairs Labelling Specialist in Santa Clara, CA for a 12-month assignment.

You will design and implement international addendum labeling (IFUs, country labels) for medical devices, coordinating with global RA teams and US product owners. Responsibilities include developing labeling strategies, ensuring compliance with FDA and international requirements, managing large-scale labeling changes, and maintaining documentation for audits and KPI