• Senior Regulatory Affairs Specialist

    Cook Medical (Bloomington, IN)


    Overview

     

    The Senior Regulatory Affairs Specialist responsible for the planning and preparation of submissions to obtain regulatory approvals for new and modified Class I, II, III and IV medical devices in specific markets. In addition to submissions, the Regulatory Affairs Specialist will serve as a communication liaison between the Cook manufacturer and the Cook Local Office / Cook Distributor.

    Responsibilities

    - Communicate and interface directly with regulatory authorities to ensure product approvals are achieved in a timely manner, if needed.- Communicate Country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assist with the regulatory strategies.- Obtain and maintain product approval, and serve as a communication liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor.- Plan and prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/regions.- Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.- Perform translation activities.- Provide support to currently marketed products as necessary including input on change requests, etc.- Collaborate with Regulatory Scientific Affairs on all high risk devices and new technologies.- Collaborate with the Clinical Functional Unit on projects requiring the collection of clinical data.- Provide support to currently marketed products as necessary including input on change requests, etc.- Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory

     

    - st 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 and ability to work in a collaborative and independent work situations and environments withminimal supervision.- Ability to remain calm and receptive in fast paced situations.

    Qualifications

    - Bachelor’s degree in a life science (preferably biology or chemistry), engineering, or other related field (such as law); or experience of such kind and amount as to provide a comparable background.- 5+ years of relevant experience.

    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.- Requires occasional early morning or late evening teleconferences.

     

    Requisition ID2025-16977

     

    Posting Date5 days ago(7/16/2025 10:31 AM)

     

    Job Location(s)Bloomington IN United States

     

    Job LocationsUS-IN-Bloomington

     

    Position TypeFull Time

     

    CompanyCook Inc - Bloomington

     

    CategoryRegulatory Affairs