Manager/Sr. Manager, Labeling Compliance

Scorpion Therapeutics; Aliso Viejo (CA); On-site; USD 107,000 - 179,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced labeling professional to oversee product labeling activities for medical devices or pharmaceuticals, ensuring regulatory compliance and quality. You will develop, review, and approve IFUs, manuals, labels, and artwork, and lead labeling changes across global markets.

The role requires 5+ years (Manager) or 8+ years (Senior Manager) in regulated labeling, strong technical writing, cross-functional collaboration with Regulatory, Quality, R&D, Clinical,

Qualifications

• 5+ years (Manager) or 8+ years (Senior Manager) in medical device/pharmaceutical industry.
• Experience with regulated product labeling, document control, and global standards.
• Strong technical writing and communication skills.
• Proficiency in Microsoft Office and Adobe Acrobat.
• Ability to manage multiple projects and collaborate cross-functionally with Regulatory, Quality, R&D, Clinical, and Commercial teams.
• Working knowledge of QMSR preferred.

Responsibilities

• Develop, control, and approve labeling content, including IFUs, manuals, labels, and artwork.
• Lead labeling change processes, including ECO/DCC activities and Labeling Committee reviews.
• Coordinate with external vendors for translations, printing, and labeling.
• Monitor global regulatory labeling requirements.
• Drive process improvements.

Skills

Project management

Technical writing

Communication

Cross-functional collaboration

Tools

Microsoft Office

Adobe Acrobat

Job description

Role

Manage and oversee product labeling activities to ensure compliance and quality for medical devices or pharmaceuticals.

Responsibilities

develop, control, and approve labeling content, including IFUs, manuals, labels, and artwork; lead labeling change processes, including ECO/DCC activities and Labeling Committee reviews; coordinate with external vendors for translations, printing, and labeling; monitor global regulatory labeling requirements; drive process improvements.

Requirements

• 5+ years (Manager) or 8+ years (Senior Manager) in medical device/pharmaceutical industry
• experience with regulated product labeling, document control, and global standards
• strong technical writing and communication skills
• proficiency in Microsoft Office and Adobe Acrobat
• ability to manage multiple projects and collaborate cross-functionally with Regulatory, Quality, R&D, Clinical, and Commercial teams
• working knowledge of QMSR preferred

HighValue

experience in regulated labeling for medical devices or pharmaceuticals, global regulatory compliance, process improvement, and cross-functional collaboration.

WorkSetup

• onsite in Aliso Viejo, CA
• salary range $107,000 - $179,200
• role level based on experience and leadership capabilities