Regulatory Compliance and Certification Specialist Job Blue Springs area,Missouri USA,Quality Assurance

Position: Career Opportunities: Regulatory Compliance and Certification Specialist (3882)

Regulatory Compliance And Certification Specialist

Fike Corporation, a rapidly growing international manufacturer of pressure relief, explosion protection, fire suppression and detection equipment, has an opportunity for a Regulatory Compliance and Certification Specialist position. Fike is a privately held business located in Blue Springs, MO with over 400 employees locally & over 1,200 employees worldwide.

At Fike, our people are our strength. In order to fulfill our greatest potential, we are committed to attracting, growing and retaining a diverse and inclusive workforce. Better, Together as oneFike!

Job Summary:

The Regulatory Compliance and Certification Specialist supports the lifecycle of regulatory certifications, approvals, and quality system compliance across all product lines. Ensures continuous compliance with applicable directives, standards, and certification body requirements while maintaining audit readiness and preventing business disruption due to lapses or nonconformances.

Primary Responsibilities:

Supports and maintains the regulatory compliance framework across all applicable jurisdictions and industries.

Actively manages expiration dates, surveillance audit cycles, and renewal lead times for certifications.

Facilitates and supports effective interaction with certification and regulatory agencies.

Plans, coordinates, and leads internal and external audits, including surveillance, recertification, ensuring complete audit readiness.

Ensures products remain compliant within the approved certification scope.

Reviews engineering changes, new product introductions, design modifications, and supplier changes for regulatory impact before implementation, driving formal change control.

Assists with certification documentation and maintains organized, audit-ready records. This includes technical files, test reports, and quality manuals, ensuring traceability between certifications, procedures, and drawings.

Provides support to the product certification process to ensure compliance with company, customer, and regulatory agency requirements.

Helps prepare training material and conducts training sessions on quality system activities.

Monitors regulatory updates and translates changes into internal requirements.

Identifies compliance risks early and escalates them clearly to leadership.

Leads investigations, addresses audit findings, tracks closure evidence, and manages corrective actions tied to regulatory nonconformance.

Helps support clear reporting and visibility on upcoming expirations, audit schedules, and overdue actions, providing updates to leadership.

Actively pursues required inputs from Engineering (drawings, technical data), Quality (procedures, CAPAs), and Operations (records, training) to ensure continuous compliance.

Works with cross-functional teams to create, modify, and execute APQP (Advanced Product Quality Planning) documents, including Process Flow, PFMEA, and Control Plans.

Drafts, revises, and releases technical procedures and work instructions

Provides support with quality documents control and distribution.

Works independently and collaboratively, demonstrating leadership in all aspects of Quality.

Maintains confidentiality of all information processed.

Performs related duties as assigned. Regular and consistent attendance is required.

Essential

Skills:

Regulatory Knowledge. ISO
9001. PED. ASME. ATEX. IECEX. AS9100. Certification Lifecycle Management. Audit Coordination and Preparation. Compliance Risk Management. Change Control. Technical Documentation Control. Cross-Functional Coordination.

Work Environment:

Work will be performed in a manufacturing, production, or office setting. While performing the duties of this job, the employee is regularly required to inspect production equipment, monitor manufacturing processes, analyze data using computer software, and collaborate with cross-functional teams. The role requires regular communication with both internal personnel and external agencies or customers. Domestic or international travel to conduct surveillance audits may be required

Required:

Bachelor of Science degree in a related discipline or equivalent work experience in lieu of degree. Three years or more of direct experience in regulatory compliance, quality, certification management, or engineering. Knowledge of relevant regulations and directives (e.g., PED, ASME, ISO 9001, ATEX, IECEX, AS9100). Experience interfacing with notified bodies, certification agencies, or auditors.

Preferred:

Lead Auditor…