Cantel Medical

  • Senior Regulatory Affairs Specialist

    Location CA-Markham
    Job ID
    2018-3769
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel Canada
  • 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

    Responsible and accountable for global regulatory affairs and compliance activities for the Cantel Medical Water Division (Mar Cor Purification) product portfolio. Lead and manage Cantel Water division RA tasks 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 senior management in determining department strategies and procedures for Cantel water division. Collaborate closely with Cantel corporate regulatory team and MN-based RA center-of-excellence to achieve enterprise business objectives. Provide leadership, guidance, strategy and manage regulatory activities for Cantel Water division 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 and vigilance reporting activities in collaboration with corporate RA team. 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 water product lines in worldwide markets. Ensure company products and operations comply with applicable regulatory standard requirements including FDA, EPA, EU MDR/MDD/REACH/BPR and ISO 13485 requirements.   
    • Lead and manage Cantel water division RA tasks to support achievement of business objectives. Assist with oversight of RA budget for water division and ensure adequate provision of RA support for business objectives.  Collaborate closely with Cantel corporate regulatory team and MN-based RA center-of-excellence to achieve Cantel enterprise business objectives.
    • 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 Water 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 senior management in establishing departmental goals, strategies and procedures in support of business objectives. Perform regulatory compliance diligence to support acquisition strategy.
    • Lead and manage execution of both pre-market regulatory and product development activities, and post-market regulatory and vigilance reporting activities in collaboration with corporate RA team.
    • 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.

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    Qualifications

    Degree in a scientific, engineering or related technical discipline with 7-8 years of experience with increasing responsibly within the regulatory affairs/compliance discipline in the life sciences industry.  Advanced degree and/or professional certification in regulatory affairs strongly preferred.  Demonstrated history of successful regulatory leadership to support business objectives.  Developed knowledge of US regulations in the areas of the FDA and EPA and international regulations such as ISO 13485 and EU MDD/MDR/REACH/BPR.  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 FDA, EPA and international regulatory submissions is required.

    Minimum Qualifications

    Cantel Medical company is an Equal Employment Opportunity/Affirmative Employer. Women, minorities, veterans, and individuals with disabilities as well as other qualified individuals are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin or other protected class status.

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