Cantel Medical

  • Regulatory Affairs Specialist

    Location US-NY-Hauppauge | US-NY-Rochester
    Job ID
    2019-4579
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel Dental
  • 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.

    Job Overview

    This position can be filled in either Plymouth, MN or Long Island, NY.


    The Regulatory Affairs Specialist is responsible and accountable for regulatory affairs and compliance activities for Cantel Dental Division global markets. Execute regulatory affairs tasks to support achievement of business objectives. Determine regulatory pathway and requirements for new and revised products. Determine and define regulatory requirements for stakeholders throughout the company. Plan, develop, prepare and execute regulatory submissions to regulatory agencies worldwide. Facilitate achievement of business objectives while ensuring compliant operation within the flexibility of the regulations. Operate in matrix organization and collaborate with Cantel corporate regulatory affairs team to achieve corporate and enterprise business objectives.

    Facilitate Cantel organizational cohesiveness and compliance consistency and integration of businesses. Responsible for both pre-market regulatory and product development activities, international submission and post-market regulatory activities. Facilitate and manage in close collaboration with quality and compliance personnel inspections and audits by applicable regulatory agencies including FDA, EPA, and EU Notified Bodies.

    Main Responsibilities

    • Execute regulatory affairs and compliance activities for Cantel Dental Division product lines in worldwide markets.
    • Ensure company products, manufacturing operations, and analytical laboratory practices comply with applicable regulatory and standard requirements including FDA, EPA, EU CE, ISO 13485, and ISO 11138 requirements.
    • Plan, develop, prepare and execute regulatory submissions to regulatory agencies worldwide. Collaborate closely with Cantel corporate regulatory affairs team to achieve corporate and enterprise business objectives.
    • Ensure design and process validations, and test methods analysis comply with applicable regulations and industry standards (i.e. FDA, ISO 11138).
    • Review and determine regulatory implications of product, labelling, and/or other documentation or design changes.
    • Participate on project teams to provided regulatory leadership and input. Provide recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the need and importance of regulatory requirements.
    • Collaborate with management in establishing departmental goals, strategies, and procedures in support of business objectives
    • Responsible for pre and post market regulatory and product development activities, international product registrations.
    • Facilitate, manage, and collaborate with quality and compliance personnel during establishment inspections and audits by FDA, EPA, and Notified Bodies.

    Qualifications

    • Degree in microbiology or similar science or related technical discipline.
    • 3-5 years of regulatory experience within US-FDA regulated industry.
    • Experience in planning and preparing FDA and international submission is required.
    • Advanced degree and professional certification in regulatory affairs is preferred.
    • Demonstrated history of successful regulatory affairs and compliance outcomes to support business objectives.
    • Knowledge of US-FDA regulations and international regulations such as ISO 13485 and EU Medical Device Directive. Familiarity ISO 11138 sterility assurance requirements is a plus.
    • Strong written and verbal communication skills, especially when dealing with governmental agencies.
    • Ability to explain and resolve difference in regulations.
    • Demonstrated experience in developmental and execution of regulatory strategy.

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