Cantel Medical

  • RA Clinical Specialist

    Location US-MN-Plymouth
    Job ID
    2018-4179
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel ENDO
  • 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:

     

    ENDOSCOPY

    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.

     

    WATER PURIFICATION AND FILTRATION

    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.

     

    HEALTHCARE DISPOSABLES

    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 RA Clinical Specialist supports and improves Cantel’s compliance position by completing clinical related tasks to support achievement of RA departmental and overall Cantel enterprise business objectives. Successfully execute clinical compliance activities for all Cantel product lines with emphasis on ensuring preparedness of clinical documentation to support compliance with EU Medical Device Regulation (MDR) requirements. Determine, define and communicate clinical requirements, assist departmental management in determining clinical strategies, plans and procedures. Determine clinical implications and requirements for new and legacy products. Conduct clinical literature review and maintain Cantel’s library of clinical literature. The position will mainly focus on development of Clinical Evaluation Reports (CERs) for all of Cantel’s products, with potential for future additional responsibility for development of other clinical evidence and claims matrix documents. The primary purpose of this job is to author and develop CERs per the current revision of MEDDEV 2.7.1, to meet essential requirements in support of submission for EU MDR CE Mark application to obtain EU market approval, recertification and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance.

    Main Responsibilities

    • Execute clinical compliance activities for all Cantel’s product lines with emphasis on ensuring preparedness of clinical documentation to support compliance with EU Medical Device Regulation (MDR) requirements
    • Responsible and accountable for development and maintenance of CERs per MEDDEV 2.7.1 for all of Cantel’s products based on product labeling, published literature, risk management documentation, complaints, post market surveillance, and adverse event reporting to create the clinical evaluation plans (CEPs) and reports.
    • Interface closely with internal customers/stakeholders and external consultants/partners to develop CEPs and CERs that meet the
      requirements of upcoming EU MDR and related current revision of clinical Evaluation MEDDEVs.
    • Responsible for overall strategy of clinical evaluation including determining equivalent devices, and may assist in the development of other clinical evidence and claims matrix documents to support product commercialization.
    • Responsible for data collection, data appraisal, data extraction from the available safety and performance data set. The Specialist will also be responsible for the final compilation/authoring of Systematic Literature Reviews (SLRs), CER assessments, new CERs and scheduled CER updates.
    • Participates in and/or performs comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies, stay informed about applicable clinical landscapes and trends and maintains library of clinical literature
    • Collaborates with other RA resources to execute proactive post-market surveillance data management, appraisal and post-market clinical follow-up projects.

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