Labelling Specialist

Labelling Specialist#26-19059 $62.16-$67.16 per hour Cupertino, CA Hybrid Job Description 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