Director, Regulatory Affairs, US

Cantel Medical Plymouth , MN 55447

Posted 5 months ago

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 OverviewDirector is responsible for product submissions and compliance activities throughout Cantel Medical North America. Plans and manages regulatory affairs departmental resources to achieve Cantel business objectives. Oversee departmental budget. Determine regulatory pathway and requirements for new and revised products. Determine and define regulatory requirements to individuals and project teams throughout the company. Plan, develop, prepare and submit regulatory submissions to appropriate agencies in the US. Facilitate achievement of business objectives while ensuring compliant operation within the flexibility of the regulations. Collaborate with management in determining department strategies and procedures. Provide guidance, strategy and manage regulatory activities/needs for all North America Cantel Medical sites. Main Responsibilities

  • Direct regulatory affairs and compliance activities for all company product lines in US markets. Ensure company products and operations comply with applicable FDA standard requirements.

  • Provide leadership and overall management of Regulatory Affairs team.

  • Plan and manage regulatory affairs departmental resources to achieve Cantel business objectives. Oversee departmental budget and ensure adequate provision of RA resources to support business needs.

  • Develop and execute regulatory strategies. Negotiate favorable outcomes with FDA, EU notified body and international regulatory agencies. Provide guidance, strategy and manage regulatory activities/needs for Cantel Medical sites.

  • 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 executive management in establishing departmental goals, strategies and procedures in support of business objectives.

Qualifications

  • Degree in a scientific, engineering or related discipline with 8+ years' experience in regulatory affairs.

  • Advanced degree and/or professional certification in regulatory affair strongly preferred.

  • Developed knowledge of US regulations in the areas of the FDA and international regulations such as ISO 13485 and EU MDD 93/42/EEC.

  • 5+ years of leadership and people 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.

  • Experience in planning and preparing US and international regulatory submissions is required. Experience in a medical device company is required.

  • General computer knowledge and experience using Microsoft Office software.

Preferred Qualifications:

  • Strong written and verbal communication skills

  • Ability to work on team

  • Strong attention to detail

  • Proficient MS Office (Word, Excel, PowerPoint, Project)

  • Ability to work well with others in a highly matrixed environment

Minimum Qualifications

Cantel 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.

Staffing and Recruiting Agencies

To all Staffing and Recruiting Agencies: The careers pages of our website are only intended for individuals and preferred suppliers of Cantel. Staffing and recruiting agencies that are not preferred suppliers are not authorized to use this site or to submit profiles, applications, resumes or CVs, or to forward resumes, CVs or applications directly to employees or any other company location, and any such submissions will be considered unsolicited.

Cantel does not accept unsolicited resumes, CVs or applications from agencies other than preferred suppliers. Cantel is not responsible for any fees related to unsolicited resumes, CVs or applications and explicitly reserve its right to contact (and hire) candidates presented in such unsolicited resumes, CVs or applications without incurring any type of a fee.

Staffing and Recruiting Agencies that are not preferred suppliers but that wish to respond to a vacancy, should contact talentacqusition@cantelmedical.com for further information.


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Director, Regulatory Affairs, US

Cantel Medical