Labelling Specialist

Our Client, a Consumer Products and Software Services company, is looking for a Labelling Specialist for their Cupertino, CA/ Hybrid location.

Responsibilities:

• Leads the Instructions for Use (IFU) creation and ensures compliance to global regulatory requirements, completes labeling reviews to verify compliance of labeling, and implements IFU with cross functional teams
• Manages marketing claims
• Coordinates internal marketing and postmarket material review/ approval
• Establishes systems for physical labeling controls
• Maintains labeling in accordance to global standards and regulatory requirements
• Provide uptodate guidance and implementation of evolving global labelling requirements
• Coordinate with Regulatory Affairs to incorporate countryspecific requirements and translations for international markets
• Participate in design and change control processes to update labelling related to new product developments product changes or regulatory updates.

Requirements:

• Bachelor's Degree, or equivalent experience.
• 25 years of experience of medical device labelling experience
• Knowledge of domestic and international medical device regulatory requirements for product labelling and unique device identification (e.g. 21 CFR 801 and EU MDR)
• Knowledge of quality management system requirements such as design change control, document control, requirements, and regulatory approvals
• Excellent written and verbal communication skills
• Excellent interpersonal skills working across multiple divisions
• Attention to detail, well organized and time efficient
• Can multitask and work independently
• Technical writing skills

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities