Regulatory Affairs Engineer

Requisition ID 2024-14541

Posting Date 36 minutes ago (5/13/2024 5:30 PM)

Job Location(s) Bloomington IN United States

Position Type Full Time

Company Cook Inc - Bloomington

Category Regulatory Affairs

Overview

The Regulatory Engineer provides technical support to Regulatory Affairs for the development of regulatory documentation for compliance with FDA and international regulatory requirements.

Responsibilities

• Act as liaison to engineering functions globally and locally to provide technical support for Regulatory Affairs
• Develop new, and refine existing, systems that provide the necessary information for successful submission to global regulatory bodies
• Help align engineering procedures and project outputs with regulatory requirements
• Assist various Regulatory Affairs staff with technical assessment and writing of regulatory submissions and responses to regulatory agencies
• Prepare regulatory submissions for new products, product changes, and re-registrations, as required
• Perform and/or coordinate required assessments for change orders and facilitate approval
• Provide product knowledge and training for Regulatory functional unit
• Coordinate regulatory initiatives and drive to completion
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision -Ability to understand the purpose of a Quality System, and to effectively and efficiently complete work within guidelines of the Cook Inc Quality System

Qualifications

• BA/BS Degree in an Engineering or Science related field required; or experience of such kind and amount as to provide a comparable background
• Experience in a FDA regulated environment and/or medical device is preferred
• Must have technical writing capabilities and strong verbal communication skills

Physical Requirements:

• Works under general office environmental conditions
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.

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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity