FDA Compliance Specialist

Location: Hybrid role based in Independence, Ohio, United States; planned and unplanned overnight travel up to 50–60%.

Salary: $71,000–$106,000 per year, plus a monthly auto allowance.

Company

hirify.global is a U.S. supplier of industrial, medical, and specialty gases, safety products, ammonia products, and process chemicals, and a subsidiary of Air Liquide.

What you will do

• Guide FDA compliance activities, regulatory assistance, and compliance auditing for drug, device, and food products.
• Partner with operations, distribution, sales, and global quality colleagues to implement and sustain FDA compliance strategies and quality systems.
• Conduct physical and paper audits of manufacturing facilities and represent hirify.global during FDA, government, and customer inspections.
• Review validation protocols and final reports, follow up on corrective actions, and draft responses to audit observations.
• Develop cGMP training materials, train Quality Control Unit members, and communicate procedural revisions to manufacturing facilities.
• Coordinate investigations of serious medical complaints and provide feedback on Annual Product Reviews and continuous improvement.

Requirements

• High school diploma or equivalent; a college degree is highly preferred.
• At least 3 years of experience auditing locations, partnering with business leaders, championing change, and representing an organization during audits.
• Experience with industrial and medical gases, especially oxygen, nitrogen, and CO2 processes.
• Knowledge of local, state, and federal laws governing drug and medical device production, plus FDA compliance rules and regulations.
• Experience resolving compliance and regulatory issues with business leaders, agencies, and public interest groups.
• Proficiency in Word, Excel, PowerPoint, and Google Workspace; willingness to travel overnight up to 50–60%.

Nice to have

• Experience in GxP/FDA-controlled environments.
• Experience in a multi-state distribution or retail organization.

Culture & Benefits

• Inclusive workplace focused on safety, customer success, sustainability, and innovation.
• Medical, dental, vision, life, disability, and AD&D insurance.
• Paid parental leave, vacation, sick time, floating holidays, and other paid leave.
• 401(k) plan with company matching, tuition assistance, tuition discounts, and scholarship opportunities.
• Benefits begin after 30 days of employment for eligible employees.