Cantel Medical

  • Regulatory Affairs Specialist

    Location US-NY-Hauppauge
    Job ID
    2018-3899
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel Healthcare Disposables
  • Company Overview

    Crosstex International is a leading global manufacturer of infection control and prevention products for the healthcare market. We create high quality, innovative products, the majority of which are manufactured in the United States. Our broad range of products for multiple healthcare disciplines include: SecureFit® Face Masks, ConFirm® Sterilization Monitoring, SaniTyze™ Waterless Antimicrobial Gel and our Patients Choice ® line of preventive products. With eleven manufacturing/distribution facilities around the world – 8 in the United States and 3 internationally – Crosstex services the global healthcare community in an efficient and timely manner. www.crosstex.com

    Job Overview

    The RA Specialist is responsible and accountable for regulatory affairs and compliance activities for Cantel Healthcare Disposables (HCD) Division (Crosstex International, Inc) products in 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 to 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. Collaborate with management in determining department strategies and procedures for Cantel HCD division. Collaborate closely with Cantel corporate regulatory team and MN-based RA center-of-excellence to achieve corporate and enterprise business objectives. Support regulatory activities for Cantel HCD 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. 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 notified EU notified bodies.

    Main Responsibilities

    • Execute regulatory affairs and compliance activities for Cantel HCD product lines in worldwide markets. Ensure company products and operations comply with applicable regulatory standard requirements including FDA, EPA, EU CE and ISO 13485 requirements.  
    • Plan, develop, prepare and execute regulatory submissions to regulatory agencies worldwide. Collaborate closely with Cantel corporate regulatory team and MN-based RA center-of-excellence to achieve Cantel corporate and enterprise business objectives.
    • Develop and execute regulatory strategies. Negotiate favorable outcomes with FDA, EU notified body and international regulatory agencies.  Support regulatory activities for Cantel HCD 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 management in establishing departmental goals, strategies and procedures in support of business objectives.
    • 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 notified EU notified bodies.

    Qualifications

    • Degree in a scientific, engineering or related technical discipline.
    • 2-4 years of experience within the regulatory affairs/compliance discipline in the life sciences industry.
    • Advanced degree and/or professional certification in regulatory affairs is preferred.
    • Demonstrated history of successful regulatory affairs and compliance outcomes to support business objectives.
    • Knowledge of US regulations in the areas of the FDA and EPA and international regulations such as ISO 13485 and EU medical device CE-marking.
    • 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.

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