Regulatory Affairs Specialist

Cook Group

. Plan and prepare submissions to obtain regulatory approvals for new and modified Class I, II, III, and IV medical devices in specific markets .

Posted 11/4/2026full-timeBloomington • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions and compliance for medical devices, including adherence to FDA 21 CFR 820 and ISO 13485 standards. Effectively communicates regulatory requirements and collaborates with cross-functional teams to ensure timely product approvals.

Highest-signal resume keywords

Regulatory SubmissionsFDA 21 CFR 820 ComplianceISO 13485 StandardsEffective CommunicationRegulatory Affairs Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory ComplianceClinical Data CollectionQuality Management SystemLicense ManagementRegulatory Strategy DevelopmentProduct Change ManagementRegistration MaintenanceHigh-Risk Device CollaborationRegulatory Record Organization

Soft Skills

Effective CommunicationCollaborationIndependenceCalm Under PressureProfessional Interaction

Certifications & Qualifications

Associate Degree in Regulatory Affairs

Industry Keywords

Medical DevicesRegulatory ApprovalsCompliance StandardsQuality ManagementRegulatory Authorities

About the role

Key responsibilities & impact

Plan and prepare submissions to obtain regulatory approvals for new and modified Class I, II, III, and IV medical devices in specific markets
Serve as a liaison on regulatory issues between the Cook manufacturer and Cook Local Office and/or Cook Distributor
Communicate region-specific regulatory requirements to Regulatory Specialist/Regulatory Science team leaders and assist with regulatory strategies
Prepare regulatory submissions for new products, product changes, and re-registrations for specific regions
Maintain registration information, including license numbers and expiration dates
Obtain re-registration approvals before license expirations to prevent disruption in product availability
Collaborate with Regulatory Scientific Affairs on high-risk devices and new technologies
Collaborate with the Clinical Functional Unit on projects requiring clinical data collection
Support currently marketed products, including input on change requests
Maintain and organize regulatory records to demonstrate compliance
Communicate directly with regulatory authorities to achieve product approvals in a timely manner
Maintain training requirements and pursue continuous development and growth
Adhere to the Quality Management System and applicable regulatory requirements

Requirements

What you’ll need

Bachelor’s degree in a related field preferred
Associate degree in Regulatory Affairs, or experience of such kind and amount as to provide a comparable background
Proficient in reading, writing and speaking the English language
Legally authorized to be employed in the United States
Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA
Must maintain all training requirements for the position
Must adhere to the Quality Management System and applicable FDA 21 CFR 820, ISO 13485, and other regulatory requirements
Must work and interact effectively and professionally throughout various levels of the global organization
Must strictly adhere to safety requirements
Must maintain regular and punctual attendance
Must maintain company quality and quantity standards
Effective communication skills and ability to work collaboratively and independently with minimal supervision
Ability to remain calm and receptive in fast-paced situations
International and domestic travel as required
Close visual acuity for working with computers and equipment
Frequently required to sit, stand, walk, and communicate

Benefits

Comp & perks

Equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and other protected classes
Reasonable accommodation under the ADA
Training requirements and opportunities for continuous development and growth