Labeling Specif Spec

Location: Santa Rosa, California
Posted On: 9/12/2017
Job Code: LSS_CA_2132
Job Description
Job Title: Labeling Specif Spec
Location: Santa Rosa CA 95403
Duration: 12 months (High possibilities of extension)

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
Labeling, label, packaging, regulatory, FDA

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Contact Details
Shubhro Biswas