• Regulatory Engineer

    Cook Medical (Bloomington, IN)


    Overview

     

    Seeking a dedicated and detail-oriented Regulatory Support Person to join our team in the medical device manufacturing industry. The ideal candidate will be responsible for ensuring our products comply with all relevant regulations and standards. This role requires excellent communication skills, a strong understanding of regulatory requirements, and the ability to work collaboratively with various stakeholders.

    Responsibilities

    + Develop and prepare regulatory compliance statements for EU-MDR, SVHC, RoHS, and other pertinent regulations.

    + Create and maintain comprehensive Full Material Disclosure (FMD) documents for all products.

    + Address customer inquiries regarding materials and product differences.

    + Lead and manage projects related to supplier-initiated changes, including modifications to raw materials and ingredients.

    + Upload and maintain data in internal and external regulatory database systems.

    + Write technical reports summarizing and analyzing the impact of changes.

    + Communicate effectively with customer regulatory personnel, supplier engineers, internal development engineers, and supplier customer service representatives.

    + Stay updated with the latest regulations and their requirements.

    Qualifications

    + Bachelor's degree in a related field (e.g., Regulatory Affairs, Engineering, Life Sciences).

    + Minimum of 3 years of experience in polymer materials, regulatory affairs or a related field, preferably in the medical device industry.

    + Strong understanding of polymers and additives used in the medical device industry.

    + Strong understanding of EU-MDR, SVHC, RoHS, and other relevant regulations.

    + Excellent communication and interpersonal skills.

    + Ability to manage multiple projects and deadlines.

    + Detail-oriented with strong organizational skills.

     

    Physical Requirements/Work Environment

     

    • Works under general office environmental conditions• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.

     

    Requisition ID2025-16306

     

    Posting Date2 months ago(3/18/2025 9:39 AM)

     

    Job Location(s)Bloomington IN United States

     

    Job LocationsUS-IN-Bloomington

     

    Position TypeFull Time

     

    CompanyCook Polymer Technology

     

    CategoryRegulatory Affairs