Change Control, Claims Management, Code of Federal Regulations, Communication Skills, Cross-Functional, Detail Oriented, Document Control, Document Management, 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
Job Title: Labelling Specialist
Location: Cupertino, CA (Hybrid)
Duration: 6+ Months with potential to extend
Pay Range: $60/67/Hr on W2 (DOE)
Mandatory:
- Bachelor's Degree, or equivalent experience.
- 2-5 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 multi-task and work independently
- Technical writing skills
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 post-market material review/ approval
- Establishes systems for physical labeling controls
- Maintains labeling in accordance to global standards and regulatory requirements
- Provide up-to-date guidance and implementation of evolving global labelling requirements
- Coordinate with Regulatory Affairs to incorporate country-specific 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
Russell Tobin offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.