Regulatory Affairs Sr. Specialist - Hardgoods

 Posted 2 hours ago
     
5-10 years experience
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AI Summary

The role involves monitoring and interpreting international safety standards to ensure compliant market access for hardgoods and instrumentation. Key duties include performing compliance assessments for new products and managing certification renewals and regulatory budgets.

It's fun to work in a company where people truly believe in what they are doing!

Are you an experienced regulatory affairs or product compliance professional with a strong understanding of hardgoods, instrumentation, and product safety requirements? 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.


Key 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.

Job 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.


What We Offer

  • 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.

If you are detail-oriented, collaborative, and motivated by the opportunity to support compliant, safe, and market-ready products, we'd love to hear from you. Join our team and help advance regulatory excellence across hardgoods and instrumentation product lines.

Come Be Part Of A Mission that Matters!

From inside the farm gate to our dinner plates, Neogen protects the world’s food supply. Through a variety of animal healthcare products, to food safety solutions for dangerous bacteria, allergens, toxins, drug residues and much more, Neogen is there — and you can be too.

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