Regulatory Affairs Associate – Hardware
Job Description:
• Monitor, interpret, and communicate updates to federal, regional, and international safety standards and related test regulations applicable to hardgoods and instrumentation products
• Provide regulatory compliance assessments for new instrumentation products and product modifications, ensuring adherence to applicable safety and performance requirements
• Collaborate with contract manufacturers and Nationally Recognized Testing Laboratories (NRTLs) to review critical component lists, support product development activities, and manage ongoing product modifications and replacement parts
• Review, edit, and proofread NRTL safety reports, related technical documentation, and instrument manuals, updating materials as needed in accordance with corporate processes
• Maintain and manage the regulatory hardgoods budget, including tracking and reviewing monthly regulatory expenses, processing purchase orders, and overseeing payments for instrument safety, EMC, emissions testing, and country certification fees
• Track and manage instrument certification timelines, including NRTL annual fees and quarterly factory inspections, and coordinate with product teams and regional regulatory partners to support global certifications (e.g., REACH, RoHS, Certificates of Compliance)
Requirements:
• Bachelor's degree in a relevant field such as Engineering, Regulatory Affairs, Quality, Science, or a related discipline, or equivalent combination of education and experience
• Demonstrated experience (typically 2-5 years) in regulatory affairs, product compliance, quality, or a related function, preferably with hardgoods, instrumentation, or technical products
• Familiarity with safety and compliance standards and processes related to NRTLs and product certifications (e.g., UL, CSA, IEC, REACH, RoHS) is strongly preferred
• Strong attention to detail with proven ability to review and edit technical documentation, reports, and manuals for accuracy and regulatory alignment
• Solid organizational and project management skills, including the ability to manage budgets, track multiple deadlines, and coordinate with internal and external stakeholders
• Effective written and verbal communication skills, with the ability to clearly convey regulatory requirements to cross-functional teams and external partners.
Benefits:
• A standard, competitive benefits package that may include health, dental, and vision insurance
• Retirement savings options
• Paid time off
Apply Now
Apply Now
• Monitor, interpret, and communicate updates to federal, regional, and international safety standards and related test regulations applicable to hardgoods and instrumentation products
• Provide regulatory compliance assessments for new instrumentation products and product modifications, ensuring adherence to applicable safety and performance requirements
• Collaborate with contract manufacturers and Nationally Recognized Testing Laboratories (NRTLs) to review critical component lists, support product development activities, and manage ongoing product modifications and replacement parts
• Review, edit, and proofread NRTL safety reports, related technical documentation, and instrument manuals, updating materials as needed in accordance with corporate processes
• Maintain and manage the regulatory hardgoods budget, including tracking and reviewing monthly regulatory expenses, processing purchase orders, and overseeing payments for instrument safety, EMC, emissions testing, and country certification fees
• Track and manage instrument certification timelines, including NRTL annual fees and quarterly factory inspections, and coordinate with product teams and regional regulatory partners to support global certifications (e.g., REACH, RoHS, Certificates of Compliance)
Requirements:
• Bachelor's degree in a relevant field such as Engineering, Regulatory Affairs, Quality, Science, or a related discipline, or equivalent combination of education and experience
• Demonstrated experience (typically 2-5 years) in regulatory affairs, product compliance, quality, or a related function, preferably with hardgoods, instrumentation, or technical products
• Familiarity with safety and compliance standards and processes related to NRTLs and product certifications (e.g., UL, CSA, IEC, REACH, RoHS) is strongly preferred
• Strong attention to detail with proven ability to review and edit technical documentation, reports, and manuals for accuracy and regulatory alignment
• Solid organizational and project management skills, including the ability to manage budgets, track multiple deadlines, and coordinate with internal and external stakeholders
• Effective written and verbal communication skills, with the ability to clearly convey regulatory requirements to cross-functional teams and external partners.
Benefits:
• A standard, competitive benefits package that may include health, dental, and vision insurance
• Retirement savings options
• Paid time off
Apply Now
Apply Now