Regulatory Compliance Specialist

Job Description

Job Description

Summary/Objective
The Regulatory Compliance Specialist (RCS) supports Cardinal’s product compliance, regulatory approvals, certification programs, risk management activities, and compliance testing efforts. The RSC works cross-functionally with Engineering, Quality, Manufacturing, and external regulatory entities to ensure products meet applicable domestic and international regulatory standards. The RCS serves as the primary coordinator for regulatory submissions, product certifications, risk management documentation, compliance testing, and legal-for-trade certification activities. The RCS will maintain documentation, coordinate approvals, manage compliance testing programs, perform VCAP testing of applicable products, end ensure compliance requirements are incorporated throughout the product development process.

The VP of Technology provides overall leadership and direction for regulatory strategy, product compliance, certification activities, and legal-for-trade programs.

Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Regulatory Affairs & Product Approvals

• Assist with obtaining and maintaining domestic and international regulatory approvals for Cardinal products.
• Coordinate communications with regulatory agencies and approval authorities worldwide.
• Prepare, organize, and maintain regulatory submissions and supporting technical documentation.
• Monitor regulatory requirements and communicate changes that may impact Cardinal products.
• Maintain regulatory records and approval documentation.
• Support product registrations and market access activities for domestic and international markets.
• Coordinate product certification activities with ETL, UL, international safety and compliance organizations, and foreign regulatory and certification agencies.
• Schedule testing, audits, inspections, and certification reviews.
• Maintain certification files and records.
• Assist Engineering with product compliance requirements throughout product development.
• Support ongoing compliance activities following product design changes or component substitutions.

Key Competencies

• Strong attention to detail
• Excellent documentation and organizational skills
• Project management and follow-through
• Ability to learn technical regulations, standards, and certification requirements
• Effective communication with internal teams and external organizations
• Ability to manage multiple projects simultaneously
• Strong analytical and problem-solving skills
• Self-motivated and able to work independently
• Proficiency with Microsoft Office and technical documentation systems

Required Education and Experience

• Bachelor’s degree in Engineering, Engineering Technology, Industrial Technology, Technical Management, Quality Systems, Business Administration, or a related technical discipline. Equivalent experience and demonstrated technical aptitude may be considered.

Preferred Education and Experience

• Experience working in a manufacturing environment
• Experience managing technical documentation.
• Experience coordinating projects involving multiple departments.
• Experience working with standards, specifications, testing, or compliance programs.
• Experience working with technical products or regulated products.

Benefits

Benefits for full-time employees include Paid Time Off, medical, dental, vision, life & disability insurance, 401k matching, Employee Referral Program, and Employee Assistance Program.

Position Type/Expected Hours of Work
This is a full-time position. Hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m., 40 hours per week. Occasional overtime may be required.