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    Clinical Affairs Specialist III - Plano, United States - Integer Holdings Corporation

    Integer Holdings Corporation
    Integer Holdings Corporation Plano, United States

    3 weeks ago

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    Description

    By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

    At Integer, our values are embedded in everything we do.

    Customer

    We focus on our customers' success

    Innovation

    We create better solutions

    Collaboration

    We create success together

    Inclusion

    We always interact with others respectfully

    Candor

    We are open and honest with one another

    Integrity

    We do the right things and do things right

    • You will adhere to Integer Core Beliefs and Values all safety, environmental, security and quality
    • requirements including, but not limited to: Quality Management Systems ( Safety, Environmental and
    • Security Management Systems, U.S. Food and Drug Administration ( regulations, company policies
    • and operating procedures, and other regulatory requirements.
    • You will contribute to global clinical strategies to support clinical evidence requirements for product
    • submissions and post submission activities.
    • You will represent the Clinical Affairs function on product development teams.
    • You will work directly with representatives from cross functional areas in possibly multiple geographical locations
    • You will ensure clinical data integrity in support of the quality and regulatory functional group needs. This will include the use of software to appraise, analyse and evaluate clinical and state of the art data to generate appropriate clinical evidence to support Integer Technologies
    • You will generate interim and final reports.
    • You will support Integer initiatives with the development and upkeep of market specific clinical training.
    • You will support investigator conferences to review findings and advise on direction.
    • You will interface with, and assure training of investigators/physicians, centre staff and Integer Clinical
    • Affairs staff.
    • You will support adequate monitoring is conducted on all clinical trials.
    • You will provide a clinical perspective and approval on field complaint investigations
    • You will work with regulatory bodies for the purpose of facilitating regulatory approvals and queries.
    • You will s upport the development of Integer technology including objectives, strategy, scope, budget, and schedule from proof of concept research, development through post market commercial phases
    • You will perform other functions as required.

    How you will be measured:

    • The specific measures listed below may be subject to change and are not intended to be an all inclusive list
    • Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health
    • Safety programs and the specific behavior based safety programs
    • You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
    • Ensure clinical data arguments provided in clinical evaluation documents are sufficient to support regulatory product approvals
    • Support revenue growth by leveraging clinical knowledge to support the growth team initiatives
    • The creation of market specific clinical training
    • Ensure documentation and data are maintained to reflect State of the Art
    • Ensure State of the Art clinical processes are maintained and continuously underpinned by current knowledge and insight gained
    • Support the Development and maintenance of the physician advisory board to and its functions as directed
    • Cost You will be expected to complete clinical inputs for product approval and product renewal within budget
    • On Time Delivery particularly those that are impacted by the results of projects that you are involved in, and deliver ed by specified milestones
    • Your expertise coupled with your accomplishments and collaboration with others to deliver
    • results will also be considered.

    What sets you apart:

    • You have a degree from higher education (Science, Engineering, Health Science, Nursing or related field
    • You have 3 years of documented professional experience; or 5-7 years of documented professional experience if a degree is not a prerequisite for a given task.
    • You have experience in medical device industry or pharmaceutical industry including US and international medical device regulatory submissions/approvals.
    • You have experience with implantable devices and/or other high risk device types.
    • You are suitably qualified as per MEDDEV rev 4), section 6.4 with experience of research methods, information management, literature reviews and technical writing.
    • You have knowledge and experience of clinical evaluations.
    • You have knowledge and experience with various medical device regulations such as the Medical Device Regulation (2017/ 21 CFR Part 812, and standards guidance documents such as MEDDEV rev 4) MDCG 2020 5, MDCG 2020 6, ICH Guidelines and their application
    • You have experience working with the medical community including physicians.
    • You have knowledge of feasibility, pivotal and post market clinical trials.
    • You can work independently as well as collaboratively within the organization.
    • You have developed good written and oral communication skills. This includes the ability to assist in teaching and training less experienced or knowledgeable associates. Clear and professional communications to all levels of the organization are important in this role
    • You have experience working in ERP systems, (such as Oracle, Reliance, etc.), Minitab, Excel, etc.
      You have leadership skills with demonstrated ability to drive positive results and deliver projects on time for deliverables and within budget.

    U.S. Applicants: EOE/AA Disability/Veteran

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