Cantel Medical

  • Sr Regulatory Affairs Specialist

    Location US-MN-Plymouth
    Job ID
    2019-5121
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel
  • 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. #CB

    Job Overview

    The Regulatory Affairs Specialist supports and improves Cantel regulatory compliance position by completing regulatory compliance related tasks to help achieve RA departmental objectives. Successfully execute EU Medical Device Regulation compliance activities across the Cantel product portfolio. Determine, define and communicate regulatory requirements to individuals and project teams throughout the company. Assist departmental management in determining strategies, plans and procedures. Determine regulatory implications and requirements for new and revised products. Prepare and submit regulatory submissions to government agencies.

    Main Responsibilities

    Prepare regulatory strategy and plan for assigned projects. Write, compile and submit regulatory submissions for assigned projects.

    • Leads, collaborate and efficiently execute projects/programs and strategies to ensure compliance to global regulatory requirements
    • Assist departmental management in determining strategies, plans and procedures.
    • Review and determine regulatory implications and requirements of product, labeling and/or other documentation or design changes.
    • Prepare regulatory strategies, plans, documentation and submissions for the products assigned.
    • Provide recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the need and importance of regulatory requirements.
    • Prepare and maintain technical files and associated documentation for products sold into the EU and other international markets.
    • Lead maintenance and organization of regulatory affairs files and documentation.
    • Assist in training of company stakeholders on new EU Medical Device Regulation requirements.

    Qualifications

    • BS degree in scientific, engineering or technical discipline with 4+ years of experience in regulatory affairs,  preferably in medical devices.
    • Masters degree in scientific, engineering or technical discipline and professional certification is preferred.
    • Strong knowledge of EU Medical Device Regulations required.
    • Demonstrated independent problem solving skills.
    • Proof of solid written and verbal communication skills, especially when dealing with governmental agencies.
    • Experience preparing European medical device regulatory submissions.
    • General computer knowledge, experience using search programs such as Access, Excel and Microsoft Word is required.

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