Labeling Specif Specialist

Location: Santa Rosa, California
Posted On: 9/12/2017
Job Code: LS_CA2128
Job Description
Position Description
This position will be responsible for supporting the development of medical device labeling for the CSH/APV businesses by coordinating across functions as well as multiple US and international sites.

Provides project leadership and orchestration of labeling changes interfacing with Marketing, R&D, Regulatory, Technical Communications, Legal, Package Engineering and site Operations
• Leads cross-functional collaboration and influences the scope of changes and labeling requirements.
• Owns development of the Labeling Requirements plans and related documentation in accordance with overall project implementation plan.
• Coordinates project plan for labeling activities to meet larger program timelines and provides inputs and influences overall project implementation plan based on label development requirements
• Clearly communicate product and project requirements to the labeling design team to ensure timely and accurate execution of key deliverables.
• Reviews product labeling including labels, cartons, IFUs and other related materials ensuring that they meet all business, medical, legal, and regulatory requirements and standards for medical devices.
• Manages the review and approval process for all new and revised labeling content
• Understands applicable global labeling regulations and standards.
• Provides recommendations to the labeling processes, quality systems, tools and/or policies focusing on continuous ways to improve efficiency and effectiveness of the process.
? Coordinates the translations of non-IFU labeling through internal or external sources
? Provides input in the creation of and compliance with standards and documented procedures for labeling development, revision and overall document management

B.A. or B.S. degree
? Minimum of 2 years of experience in packaging, labeling or relevant regulated industry
? Highly detail oriented & able to manage multiple priorities
? Experience working in business systems including Excel and other MS Office programs
Category:IT  code:new
Job Requirements
MS Office, Compliance, Management, Engineering, COM, Marketing, STE, MS Excel

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Contact Details
Ebrahim Sayarwala