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Package Operator in Mounds View at Collabera

Date Posted: 8/24/2018

Job Snapshot

Job Description

Position Description:
This position will be responsible for supporting the development of medical device labeling for the ECT business by coordinating across functions as well as multiple US and international sites.

Position Responsibilities:
Provides project leadership and orchestration of labeling development activities interfacing with Marketing, R&D, Regulatory, Technical Communications, Legal, and Package Engineering, site Operations, and other relevant business partners.
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.
Coordinates the translations of non-IFU labeling through internal or external source
Provides input in the creation of and compliance with standards and documented procedures for labeling development, revision and overall document management

Job Requirements

Experience in packaging, labeling or relevant regulated industry
Experience managing complex projects on cross-functional teams
Experience working in business systems including Excel and other MS Office programs
Comfortable learning and using new computer systems and programs