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Regulatory Reporting Specialist

Company: Cook Group
Location: Bloomington
Posted on: June 24, 2022

Job Description:

The Regulatory Reporting Specialist is responsible for the timely delivery of responses to inquiries from regulatory authorities. - The Regulatory Reporting Specialist coordinates with Regulatory Affairs, Regulatory Scientific Affairs, Quality Engineering, and other Cook companies globally in reviewing, preparing, and reporting adverse events to regulatory authorities. ---- Based on information received, review regulatory reports, and develop and coordinate responses to inquiries from regulatory authorities--- Review product complaints received from Cook global distribution centers--- Plan, review, and prepare appropriate regulatory reports based on assessments--- Collaborate with Regulatory Scientific Affairs on all high risk devices --- Communicate with other Cook companies globally as necessary for reporting--- Generate responses to inquiries on adverse event reports from various global regulatory authorities --- May communicate directly with the regulatory authorities to ensure inquiries are received in a timely manner --- Generate various reports as requested from internal and external customers--- 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 oral, written and presentation communication skills--- Ability to work in collaborative and independent work situations and environments with minimal supervision --- Ability to remain calm and receptive in fast paced situations--- Must have excellent analytical and problem solving skills - -Minimum Work Experience/Educational Requirements ---- Bachelor's degree in a related field preferred--- Quality experience preferred--- Proven project management skills -Physical Requirements/Work Environment ---- Requires occasional early morning or evening teleconferences--- Must be willing and able to travel as needed--- Works under general office environmental conditions--- Sits for extended periods, utilizes close visual acuity for working with - computers, etc. -

Keywords: Cook Group, Bloomington , Regulatory Reporting Specialist, Advertising , Bloomington, Indiana

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