Cantel Medical

Senior Regulatory Affairs Manager

US-NY-Hauppauge
Job ID
2017-3451
# Positions
1
Category
Quality / Regulatory
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 – 7 in the United States and 3 internationally – Crosstex services the global healthcare community in an efficient and timely manner. www.crosstex.com

Job Overview

Responsible and accountable for regulatory affairs and compliance activities for the Cantel Medical Healthcare Disposables (HCD) Division (Crosstex International, Inc) product lines in worldwide markets. Lead and manage Cantel HCD division RA department in order 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 HCD division. Collaborate closely with Cantel corporate regulatory team and MN-based RA center-of-excellence to achieve corporate business objectives. Provide leadership, guidance, strategy and manage 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. 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. 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 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.   
  • Lead and manage Cantel HCD division RA department in order to support achievement of business objectives. Oversee RA departmental budget and ensure adequate provision of RA resources in order to support business needs.  Collaborate closely with Cantel corporate regulatory team and MN-based RA center-of-excellence to achieve Cantel corporate 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 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 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. 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 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 medical device CE-marking.  Management experience in regulated industry required.  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.

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