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Labelling Specialist

Iconma

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
3 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.
  •  
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

I

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/