Global Medical Device Labeling Operations Specialist

The Fountain Group; Sunnyvale (CA); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Life insurance

Disability insurance

Job summary

The Fountain Group in Sunnyvale is seeking a Regulatory Labeling Specialist to design, revise, and implement international medical device labeling, including IFUs and country-specific labeling, ensuring compliance with FDA and global requirements.

You will independently manage multiple labeling projects, coordinate redline reviews, approvals, and labeling releases while supporting centralized international labeling processes and collaborating with Regulatory Affairs, Quality, Packaging, and

Qualifications

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or related field is required.
• 4+ years of experience in Regulatory Affairs, regulatory compliance, quality, or related operations within a regulated industry is required.
• Hands-on experience developing, revising, and implementing regulatory labeling, including labeling changes, redlines, and approval workflows, is required.
• Strong knowledge of medical device labeling regulations, including FDA and international regulatory requirements, is required.
• Experience with change control, regulatory documentation, and quality system procedures is required.
• Direct experience with medical device labeling, including IFUs, import labels, and country-specific labeling, is preferred.
• Experience independently managing multiple labeling projects and coordinating with cross-functional regulatory, quality, and packaging teams is preferred.
• Experience with SAP/SAP MD, Adobe Acrobat Pro, and document management systems is preferred.

Responsibilities

• Designing, developing, revising, and implementing international medical device labeling to ensure compliance with FDA and international requirements.
• Manage multiple post-approval labeling change projects, coordinating reviews, approvals, and labeling releases.
• Collaborate with Regulatory Affairs, Quality, Packaging, and Labeling teams to assess regulatory changes and drive process improvements.

Skills

Regulatory labeling

Regulatory compliance

Project coordination

Cross-functional collaboration

Education

Bachelor's degree in Regulatory Affairs or Biomedical Engineering

Tools

SAP/SAP MD

Adobe Acrobat Pro

Document management systems

Job description

The Fountain Group in Sunnyvale is seeking a Regulatory Labeling Specialist to design, revise, and implement international medical device labeling, including IFUs and country-specific labeling, ensuring compliance with FDA and global requirements.

You will independently manage multiple labeling projects, coordinate redline reviews, approvals, and labeling releases while supporting centralized international labeling processes and collaborating with Regulatory Affairs, Quality, Packaging, and