Regulatory Affairs Sr. Specialist - Hardgoods

Neogen Corporation

3d

About The Position

We are seeking a Regulatory Affairs Sr. Specialist - Hardgoods to support regulatory compliance activities for instrumentation and related food safety product lines. In this manager-grade role, you will help monitor evolving standards, support certification and documentation processes, and collaborate with internal and external partners to help maintain compliant market access.

Requirements

• Experience in regulatory affairs, product compliance, product stewardship, quality, engineering compliance, or a related function supporting hardgoods, instrumentation, or food safety product lines.
• Working knowledge of instrument safety, EMC, emissions, certification processes, and regulatory compliance expectations for marketed products.
• Experience reviewing technical documentation such as NRTL reports, safety reports, critical component lists, certification records, manuals, or compliance assessments.
• Strong written and verbal communication skills, with the ability to clearly explain regulatory requirements, documentation needs, and compliance updates to internal and external stakeholders.
• Demonstrated organizational skills and attention to detail, with the ability to manage multiple priorities, timelines, purchase orders, budget activities, and renewal deadlines.
• Ability to work independently and collaboratively while using sound judgment to escalate compliance risks, certification timing concerns, or budget issues appropriately.

Responsibilities

• Monitor, interpret, and communicate updates to applicable federal, regional, and international safety standards, test standards, and regulatory requirements for hardgoods and instrumentation product lines.
• Provide regulatory compliance assessments for new products, product modifications, replacement parts, and lifecycle changes to support compliant development, launch, and ongoing marketability.
• Review technical and compliance documentation, including critical component lists, NRTL safety reports, certification records, compliance reports, and instrument manuals.
• Partner with product teams, contract manufacturers, NRTLs, regional regulatory teams, quality, procurement, finance, and other stakeholders to support certification, testing, and documentation needs.
• Track certification expiration dates, renewals, testing timelines, factory inspections, and related activities to help prevent compliance delays or market access interruptions.
• Support regulatory budget tracking, purchase order processing, invoice coordination, and fee management for testing, certifications, inspections, and related compliance activities.

Benefits

• Ongoing training and development to strengthen technical regulatory knowledge, certification expertise, and lifecycle compliance capabilities.
• A standard benefits package, wellbeing resources, and development support in accordance with applicable company policies and business practices.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed