Senior Regulatory Affairs Specialist – Hardgoods

🔥 2 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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Neogen Corporation

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

🌾 Agriculture

🍽️ Food & Beverage

Biotechnology • Agriculture • Food & Beverage

Neogen Corporation is a biotechnology company that offers a comprehensive range of solutions and services aimed at ensuring food safety throughout the food chain. They cater specifically to the food processing, animal protein, and agriculture industries, helping to protect the global food supply while promoting efficient production practices. In addition to their primary focus on food safety, Neogen also serves the companion and performance animal sectors, as well as engaging in life sciences and toxicology fields.

📋 Description

• 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.

🎯 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.

🏖️ Benefits

• The opportunity to contribute to product safety, regulatory compliance, and continued market access for hardgoods, instrumentation, and food safety product lines. • A collaborative, cross-functional work environment with opportunities to partner with product teams, contract manufacturers, NRTLs, regional regulatory teams, and global stakeholders. • Ongoing training and development to strengthen technical regulatory knowledge, certification expertise, and lifecycle compliance capabilities. • Opportunities to support new product development, product modifications, certification renewals, and global compliance activities in a dynamic business environment. • A standard benefits package, wellbeing resources, and development support in accordance with applicable company policies and business practices.