Product Labeling Supervisor

Steris Corporation•Conroe, TX

5d•Onsite

About The Position

The Product Labeling Supervisor is responsible for leading the product labeling team, executing labeling projects, and ensuring label management follows all applicable policies and procedures. In this role, you will provide project leadership and orchestration of labeling development activities interfacing with Marketing, R&D, Regulatory, Technical Communications, Legal, Package Engineering, and site Operations. This role requires working onsite in our Conroe Texas location.

Requirements

Bachelor’s degree in science or communication related field.
In lieu of a degree, high school diploma or GED and 8 years of experience.
Product Labeling and project management experience.
Minimum of 3 years product labeling experience and project management experience for medical device or other regulated industry.
Proficiency with common content management tools and systems.
Experience with document management systems (PLM).
Knowledge of medical device regulations and standards relating to labeling and regulated documentation.

Nice To Haves

Technical writing proficiency is highly desirable with emphasis on medical device product labeling development.
Experience in working within a regulated industry.
Software experience with Propel PLM, Adobe Illustrator, InDesign, preferred
Label Matrix, Nice Label, Bartender, strongly preferred
Self-motivated and able to work independently with limited supervision, making informed decisions based on analysis
Strong interpersonal skills
Excellent written and verbal communication skills
High level of detailed accuracy

Responsibilities

Provides direction on label management processes and project prioritization and execution
Creates and modifies labeling for product instruction for use (IFU) documents, labels, cartons and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices following the established design format, labeling style guidelines and branding guidelines.
Leads activities for new and updated labels from creation, through First Article Inspection (FAI) through the change control process.
Monitors changes in labeling regulations in the US and/or abroad and ensures that labeling meets all medical, legal, and regulatory requirements
Confers with label package change initiators to assess business needs and to determine their requirements to help solve problems in an innovative, cost effective and timely manner
Ensures all requested projects have appropriate labeling resources assigned to enable on-time completion of project goals
Contributes to the development of solutions and best practices for labeling initiatives, including recommending activities involving legacy systems, process improvement, country-specific requirements, labeling standards and regulations, and labeling stakeholders
Communicates with vendors regarding ongoing labeling operations
Works with outside vendors on content translations for labels and IFUs
Controls and manages numerous product labeling project tasks that culminate in release to production via the engineering change process