Regulatory Scientist at Cook Polymer Technology in Bloomington, Indiana

Job Description:

Regulatory Scientist

Requisition ID 2025-16306

Posting Date 1 hour ago (3/18/2025 4:39 PM)

Job Location(s) Bloomington IN United States

Job Locations US-IN-Bloomington

Position Type Full Time

Company Cook Polymer Technology

Category Regulatory Affairs

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.

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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.