Cantel Medical

  • Regulatory Affairs Associate

    Location US-MN-Plymouth
    Job ID
    2019-4510
    # 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.

    Job Overview

    The Regulatory Affairs Associate supports and improves Cantel regulatory compliance position by completing regulatory compliance related tasks to help achieve RA departmental objectives. Works with local regulatory agents and distributors to assist in preparation, compilation and maintenance of regulatory registrations to government agencies. Assist in the determination and definition of regulatory requirements for project teams and stakeholders throughout the organization.

    Main Responsibilities

    • Manage regulatory affairs and compliance activities for company product lines in both domestic and international markets.
    • Assist in the determination and definition of regulatory requirements for project teams and stakeholders throughout the organization.
    • Collaborate with product development project teams to execute regulatory strategies for global registrations and compliance.
    • Work with local regulatory agents and distributors to assist in the preparation, compilation and maintenance of regulatory registrations.
    • Obtain CFGs and co-ordinate document legalization to support international regulatory submissions.
    • Complete change control documentation for regulatory related product and label changes.
    • Have a basic understanding of pertinent ISO/FDA/EU/EPA regulations, standards and guidance documents that dictate compliance requirements for all Cantel products.
    • Assist in implementing department procedures to ensure compliance with Regulatory and Corporate requirements.
    • Perform other related duties and assignments to support the RA team as required.

    Qualifications

    • BS/BA degree in an engineering or scientific discipline with 0-2 years of experience in regulatory affairs/compliance. Bachelor or Master’s degree in Electrical, Chemical or Biomedical Engineering is preferred.
    • Basic knowledge of FDA, ISO and EU regulations pertaining to medical devices including the European Union Medical Device Regulation.
    • Strong regulatory compliance documentation skills. Experience in preparing regulatory submissions and associated documents legalization is preferred.
    • Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
    • Strong written and verbal communication, problem solving and analytical skills.
    • General computer knowledge and working ability using Microsoft Office programs.

    #CB

    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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