Cantel Medical

  • Labeling Project Leader

    Location US-MN-Plymouth
    Job ID
    2018-4010
    # Positions
    1
    Category
    Purchasing / Materials/ Supply Chain
    Company
    Cantel ENDO
  • Company Overview

    At Cantel, preventing infection is our business. We are dedicated to delivering high-quality, innovative solutions that help our customers improve patient care. Choosing a career with Cantel means joining a company that’s driven by an entrepreneurial spirit and the passion to shape the future of infection prevention. If you want to be inspired by your work and have a hand in shaping the future of infection prevention, we want to meet you. Come and see why people love working here.

     

    Cantel is a leading global company dedicated to delivering innovative infection prevention products and services for patients, caregivers, and other healthcare providers which improve outcomes, enhance safety and help save lives.  Our products include specialized medical device reprocessing systems for endoscopy and renal dialysis, advanced water purification equipment, sterilants, disinfectants and cleaners, sterility assurance monitoring products for hospitals and dental clinics, disposable infection control products primarily for dental and GI endoscopy markets, dialysate concentrates, hollow fiber membrane filtration and separation products. Additionally, we provide technical service for our products. Cantel medical is a leading provider of infection prevention products and services in the healthcare market, specializing in the following operating units:

     

    ENDOSCOPY

    Endoscopy procedure disposables include single-use valves and irrigation tubing. Medical device reprocessing systems, disinfectants, detergents and other supplies are used to disinfect high-level endoscopes. This segment is operated through MEDIVATORS.

     

    WATER PURIFICATION AND FILTRATION

    Water purification systems for dialysis facilities, including hemodialysis dialyzer and reprocessing systems, as well as sterilants and filtration products. This segment is operated through Mar Cor Purification, Inc. and MEDIVATORS.

     

    HEALTHCARE DISPOSABLES

    Single-use, infection prevention products used primarily in the dental market including face masks, sterilization pouches, towels and bibs, tray covers, saliva ejectors, germicidal wipes, plastic cups and disinfectants. This segment is operated through Crosstex International, Inc.

    Job Overview

    As the Labeling Project Leader, you will be responsible for the overall coordination, development and execution of Global Labeling Projects for Cantel Medical.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. The Labeling Project Leader will also support the development of solutions for labeling initiatives, including recommending activities involving:
    • Input in to Labeling software and infrastructure design
    • Legacy and new documentation and change management systems and processes
    • Country-specific requirements, including relevant standards and regulations
    • Root cause analysis and other process improvement techniques

    Main Responsibilities

    • Creation of global standard and templates for new and existing products including product labeling, IFU’s and other forms of regulated packaging material
    • Monitors changes in labeling regulations in the US and/or abroad and ensures that labeling meets all medical, legal, and regulatory requirements
    • Ensures all requested projects have appropriate labeling resources assigned to enable on-time completion of project goals
    • Monitor, evaluate and recommend improvements to labeling processes, quality, systems tools and/or policies.
    • Leads, directs and reviews the work of a team who exercise latitude and independence in their assignments
    • Establishes operational plans and implements policies and strategies
    • May have budget accountability for a department or function
    • Strive for continuous improvement and consistency in deliverables
    • Communicates with internal and external customers and vendors regarding ongoing operations
    • Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties
    • Confer with label package change initiators to assess business needs and to determine their requirements in order to help solve problems in an innovative, cost effective and timely manner
    • Establish personal rapport and achieve acceptance with cross functional team members by explaining labeling processes and developing compliant cost effective, fast-to-market solutions.
    • Build sustainable relationships of trust through open and collaborative communications
    • Collaborate with label change request initiators to plan, prepare and submit complete and accurate change requests.
    • Drives labeling activities to initiate and deliver to Operations labeling content changes through updates to product labels, instructions for use (IFU) and other forms of regulated labeling materials in compliance with global and regional standards and regulations.
    • Interpret, analyze, compare and make decisions regarding existing content in a labeling content system, in collaboration with labeling stakeholders, to support the design of labels and IFUs
    • 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
    • Evaluates risks, identifies alternatives, and proposes labeling approaches to resolve critical issues
    • Provides guidance to management in identifying/executing alternate strategies to facilitate or accelerate delivery
    • Prepare and deliver training presentations explaining services and processes of Global Labeling to different Business Units.
    • Attends project meetings including Project initiation meetings, Operational meetings, etc.

    Qualifications

    • Four-year college science-related Degree (Bachelors)
    • Minimum of 3 years labeling experience, preferably in the following areas:
      • Developing labeling for medical devices for FDA and global markets.
      • Developing or improving documentation (e.g. SOPs) in an FDA regulated industry.
    • Strong interpersonal skills, both for building relationships with cross functional teams quickly, as well as effectively communicating with other across Cantel.
    • Project Management Professional desired
    • Strong relationship management and communication skills, both oral and written, in order to influence others and operate effectively with ambiguous situations.
    • Customer orientation and ability to adapt/respond to different types of characters
    • Must be able to listen to the customer’s requirements, desires and concerns, and then recommend solutions, possibly including customizing a path forward to a variety of problems of moderate scope and complexity.
    • Self-motivated and able to work independently with limited supervision, making informed decisions based on analysis
    • Moderate Knowledge of medical device regulations and standards relating to labeling and regulated documentation
    • Action-oriented and customer-focused to deliver consistent, quality results
    • Ability to function well under pressure
    • Flexible to balance day-to-day delivery at the same time as unanticipated activities
    • High level of detailed accuracy
    • Experience with content management, translation, labeling graphics design and proofreading systems desirable
    • Skills in Microsoft Word, Excel, PowerPoint, and Outlook require
    • Good knowledge of project management software tools such as Microsoft Project

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