Cantel Medical

  • Principal Regulatory Affairs Specialist

    Location US-MN-Plymouth
    Job ID
    2019-5285
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel
  • 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:
    Medical
    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.
    Life Sciences
    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.
    Dental
    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.

    #CB

    Job Overview

    The Principal Regulatory Affairs Specialist (RAS) is responsible for developing regulatory strategy, preparing
    U.S. and EU submissions, while supporting approval for Cantel products globally. This position translates
    regulatory requirements into project/product requirements, prepares regulatory submissions and
    negotiates approval with regulatory agencies. The Principal RAS supports both pre-market and postmarket business goals, and mentors/coaches other regulatory staff members. The role focuses on U.S. and
    EU Class I and II medical devices working in a collaborative team environment

    Main Responsibilities

    Lead preparation of US FDA submissions, EU Technical Files, and internal documentation for product
    changes and new product development.
     Work with regulatory and cross-functional peers to resolve potential regulatory/technical issues and
    questions from the regulatory agencies.
     Reside on product development teams/project teams in providing regulatory feedback and guidance.
     Assists with training of other regulatory affairs staff members.
     Reviews device labeling and advertising materials for compliance to applicable regulations and
    submissions.
     Provide support for currently marketed products by reviewing product changes and documentation and
    assessing the regulatory impact of those changes.
     Provide recommendations for how to overcome regulatory barriers and resolve any disputes within teams
    as to the need and importance of regulatory requirements.
     Acts as company representative, developing and maintaining positive relationships with regulatory
    authorities.
     Maintain proficiency in regulatory standards and requirements.
     Develop and maintain procedures to ensure compliance and support business goals.

    Qualifications

    Bachelor’s Degree
     6-8 years of regulatory experience in medical devices
     Experience in writing regulatory submissions
    Preferred Qualifications:
     Master’s degree in scientific, engineering or technical discipline
     Expertise in U.S. 510(k)s and EU Technical Files
     Ability to write clear, understandable technical documents
     Able to compile data and summarize results
     Ability to effectively manage multiple projects and priorities

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