Global Regulatory Compliance & Certification Expert

National MS Society; Blue Springs (MO); On-site; USD 67,527 - 84,402; Full time

Benefits offered by this job

Three Weeks PTO

Medical, Vision & Dental Plans

401(k) with Company Match

Profit Sharing Bonus Program

Education Reimbursement

Employee Assistance Program

On-Site Fitness Center & Wellness

Job summary

Fike Corporation in Blue Springs, MO is seeking a Regulatory Compliance and Certification Specialist to manage regulatory certifications, audits, and quality-system compliance across product lines. You will maintain audit readiness, track expirations, coordinate with certification bodies, and ensure changes stay within approved certification scope.

The role requires a BS in a related field or equivalent experience, 3+ years in regulatory compliance or quality, and experience with PED, ASME, ISO

Qualifications

• Bachelor degree or equivalent experience with regulatory/compliance background.
• Experience with certification bodies and audit processes.
• Knowledge of regulatory directives and standards listed in essential skills.

Responsibilities

• Maintain regulatory compliance framework across jurisdictions and industries.
• Manage certification expirations, surveillance cycles, and renewal lead times.
• Coordinate audits, including surveillance and recertification activities.
• Ensure products stay within approved certification scopes and drive change control.
• Prepare and maintain audit-ready technical files, test reports, and quality manuals.

Skills

Regulatory Knowledge

ISO9001

PED

ASME

ATEX

IECEX

AS9100

Certification Lifecycle Management

Audit Coordination

Compliance Risk Management

Change Control

Technical Documentation Control

Cross-Functional Coordination

Education

Bachelor of Science in a related discipline

Job description

Fike Corporation in Blue Springs, MO is seeking a Regulatory Compliance and Certification Specialist to manage regulatory certifications, audits, and quality-system compliance across product lines. You will maintain audit readiness, track expirations, coordinate with certification bodies, and ensure changes stay within approved certification scope.

The role requires a BS in a related field or equivalent experience, 3+ years in regulatory compliance or quality, and experience with PED, ASME, ISO