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Labelling Specialist

ICONMA, LLC

Cupertino, CA

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JOB DETAILS
SALARY
$62.16–$67.16 Per Hour
SKILLS
Change Control, Claims Management, Code of Federal Regulations, Communication Skills, Consumer Software, Cross-Functional, Detail Oriented, Document Control, Document Management, Health Plan, High Tech Industry, Interpersonal Skills, Maintain Compliance, Marketing, Medical Equipment, Multitasking, Organizational Skills, Presentation/Verbal Skills, Quality Management, Quality System Requirements (QSR), Regulations, Regulatory Requirements, Technical Writing, Writing Skills
LOCATION
Cupertino, CA
POSTED
4 days ago
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.
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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?

About the Company

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ICONMA, LLC