• Post Market Surveillance Specialist

    Posting Date 2 weeks ago(7/30/2018 2:22 PM)
    Requisition ID
    2018-4992
    Job Location(s)
    Bloomington IN United States
    Position Type
    Full Time
    Company
    Cook Inc.
    Category
    Regulatory Affairs
  • Overview

    The Post Market Surveillance Specialist is to support the reporting process, assuring compliance with national and international regulations.

    Monitor the performance of a medical device after release to the market. Ensure Post Market Surveillance plans and reports are consistent

    with applicable regulations, standards, and established procedures.

    Responsibilities

    • Collaborate with functional teams to collect, review, and analyze data for the Post Market Surveillance (PMS) process

    • Schedule and facilitate Post Market Surveillance meetings to discuss plans and reports

    • Collect, review, and edit Post Market Surveillance data for Clinical Evaluation Reports

    • Generate plans and reports to ensure compliance with evolving regulations

    • Monitor, track, and communicate project progress to leadership

    • Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements

    • Ability to prioritize workload and meet project deadlines

    • Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth

    • Must work and interact effectively and professionally with and for others throughout various levels of the global organization

    • Must strictly adhere to safety requirements

    • Maintain regular and punctual attendance

    • Must maintain company quality and quantity standards

    • Must have effective communication skills, which may include oral or written

    • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision

    • Ability to remain calm and receptive in fast paced situations

    Qualifications

    • Bachelor’s degree required or experience of such kind and amount as to provide a comparable background

    • Minimum 1 year experience in the field of Post Market Surveillance in the medical device industry preferred

    • Must be proficient with Microsoft Word, Excel and PowerPoint

     

    Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

     

    Physical Requirements:

    • Works under general office environment conditions

    • Utilizes close visual acuity for working with computers and equipment

    • Frequently required to sit, stand, walk, and communicate

    • Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA

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