✨ AI Insights & Summary
Cardinal is seeking a detail-oriented Regulatory Compliance Specialist (RCS) to ensure its products meet rigorous domestic and international standards. This role offers a fantastic opportunity to be at the heart of product development, collaborating cross-functionally to manage regulatory submissions, certifications, and compliance testing. If you have a strong technical aptitude, exceptional organizational skills, and a passion for navigating complex regulatory landscapes, this position provides a stable, full-time role with comprehensive benefits and the chance to make a tangible impact on product marketability and safety.
Summary/Objective
The Regulatory Compliance Specialist (RCS) supports Cardinal’s product compliance, regulatory approvals, certification programs, risk management activities, and compliance testing efforts. The RCS 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, and 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
- Regulatory Affairs & Product Approvals:
- Assist in obtaining and maintaining domestic and international regulatory approvals.
- Coordinate communications with global regulatory agencies and approval authorities.
- Prepare, organize, and maintain regulatory submissions and supporting technical documentation.
- Monitor regulatory requirements and communicate changes impacting Cardinal products.
- Maintain regulatory records and approval documentation.
- Support product registrations and market access activities globally.
- Coordinate product certification activities with ETL, UL, international safety organizations, and foreign regulatory bodies.
- Schedule testing, audits, inspections, and certification reviews.
- Maintain certification files and records.
- Assist Engineering with product compliance requirements throughout the product development lifecycle.
- 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 capabilities
- 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 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 or regulated products.
Benefits
- Paid Time Off (PTO)
- Medical, dental, and vision insurance
- Life & disability insurance
- 401k matching
- Employee Referral Program
- Employee Assistance Program
Position Type/Expected Hours of Work
- Full-time position.
- Monday through Friday, 8:00 a.m. to 5:00 p.m. (40 hours per week).
- Occasional overtime may be required.