Cantel Medical

  • Senior Manager, Regulatory Affairs

    Location US-MN-Plymouth
    Job ID
    2019-5219
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel Medical
  • 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

    Responsible and accountable for regulatory affairs and compliance activities for Cantel Medical product lines in
    worldwide markets. Lead and manage Cantel RA staff to support achievement of business objectives. Determine
    regulatory pathway and requirements for new and revised products. Determine and define regulatory requirements to
    stakeholders throughout the company. Plan, develop, and oversee preparation of regulatory submissions to regulatory
    agencies worldwide. Facilitate achievement of business objectives while ensuring compliant operation within the
    flexibility of the regulations. Collaborate with cross-functional peers in determining department strategies and
    procedures for Cantel Medical. Collaborate with Cantel cross-functional teams to achieve corporate business objectives.
    Provide leadership, guidance, strategy and manage regulatory activities for Cantel Medical and global subsidiaries in
    Cantel matrix organization. Facilitate organizational cohesiveness with the Cantel regulatory philosophy and improve
    regulatory compliance consistency and integration of Cantel businesses. Perform regulatory compliance diligence to
    support acquisition strategy. Responsible to lead and manage execution of both pre-market regulatory and product
    development activities, and post-market regulatory. Facilitate and manage in close collaboration with quality and
    compliance personnel inspections and audits by applicable regulatory agencies including FDA, EPA and notified EU
    notified bodies.

    Main Responsibilities

    Lead regulatory affairs and compliance activities for Cantel Medical product lines in worldwide markets. Ensure
    company products and operations comply with applicable regulatory requirements.
     Direct development and execution of regulatory strategies. Negotiate favorable outcomes with FDA, EU notified
    body and international regulatory agencies. Provide leadership, guidance, strategy and manage regulatory
    activities/needs for Cantel Medical division and global subsidiaries in Cantel matrix organization.
     Determine and define regulatory requirements to stakeholders throughout the company. Review and determine
    regulatory implications of product, labeling and/or other documentation or design changes.
     Participate on project teams to provide 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 cross-functional peers in establishing departmental goals, strategies and procedures in support
    of business objectives. Perform regulatory compliance diligence to support acquisition strategy.

    Qualifications

    • Degree in a scientific, engineering or related technical discipline.
    • 7-8 years of experience with increasing responsibly within the regulatory affairs function.
    • Demonstrated history of successful regulatory leadership to support business objectives.
    • People management experience in regulated industry.
    • Developed knowledge of US and EU medical device regulations.
    • Proof of strong written and verbal communication skills, especially when dealing with governmental agencies.
    • Ability to explain and resolve differences in regulations.
    • Demonstrated experience in development and execution of regulatory strategy.
    • Experience in planning and preparing US FDA and EU Notified Body regulatory submissions

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