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.
Originally posted on Himalayas
