Regulatory Compliance and Certification Specialist

Fike Corporation, a rapidly growing international manufacturer of pressure relief, explosion protection, fire suppression and detection equipment, is a privately held business located in Blue Springs, MO with over 400 employees locally and over 1,200 employees worldwide. At Fike, our people are our strength, and we are committed to attracting, growing, and retaining a diverse and inclusive workforce.

About the role

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.

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 and 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, including 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.

Requirements

• 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 Qualifications

• Lead Auditor Certification.

Skills

• Regulatory Knowledge (ISO9001, 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. The role requires regular communication with both internal personnel and external agencies or customers, as well as domestic or international travel to conduct surveillance audits.

Pay

The pay range for this position is $67,527–$84,402 per year and may increase depending on the level of experience of the candidate.

Benefits

• Three weeks Paid Time Off (PTO) and paid holidays
• Medical plans with FSA and HSA, vision, and dental plan
• Paid life and long-term disability insurance
• 401(k) and Roth 401(k) plan with company match (fully vested on day one)
• Profit-sharing bonus program
• Education reimbursement
• Employee Assistance Program
• On-site fitness center and award-winning wellness program
• Reimbursement for safety shoes and glasses
• Service awards and recognition program
• Company picnic, quarterly events, and holiday lunch
• Free coffee/tea, lunch utensils, lunch room mini-mart, and free parking