Sr Regulatory Engineer

Summary

The Regulatory Engineer is a key member of the Company Global Research & Development team, responsible for ensuring that new and existing products are designed, tested, and documented to meet applicable regulatory and certification requirements. This role focuses on achieving maintaining compliance with Factory Mutual (FM), ATEX, and CE certification standards and works cross-functionally with engineering, manufacturing, and external certification bodies to support successful product launches and lifecycle compliance.

Essential Functions

• Serve as the regulatory and certification subject matter expert for Factory Mutual (FM), ATEX, and CE requirements throughout product development lifecycle.

• Partner with product development, mechanical, electrical, and software engineering teams to integrate regulatory requirements product designs from concept through release.

• Interpret applicable standards, directives, and codes (e.g., ATEX Directive, CE marking requirements, FM Approval Standards) and translate them into actionable design and testing requirements.

• Develop and maintain regulatory compliance plans, certification strategies, and risk assessments for new and modified products.

• Act as the primary technical interface with external certification bodies, notified bodies, and test laboratories.

• Documentation Preparation: Prepare and submit regulatory documentation to relevant authorities, ensuring accuracy and completeness.

• Cross-Functional Collaboration: Work closely with team in research & development, quality, manufacturing, and supply chain to integrate compliance measures early in the new product development process.

• Regulatory Reviews: Conduct regulatory reviews and risk assessments to identify potential compliance issues and recommend solutions.

• Monitoring Regulations: Stay updated on changes in regulations and industry standards, advising the organization on necessary adjustments to maintain compliance.

• Training and Guidance: Provide training to staff on regulatory requirements and best practices, fostering a culture of compliance within the organization.

• Audit Participation: Facilitate regulatory inspections and audits, ensuring that all processes adhere to established standards.

• Due to the Global Sales and Distribution of our products, the regulatory standards may include, but are not limited to the following: ATEX, Class 1 - Div 1, UL, CE, UKCA (UK Conformity Assessed), CSA, FM, Machinery Directive and Safety Compliances.

Qualifications

• Bachelor’s degree in engineering or related field is required

• 3 to 5 years of experience in a regulatory role for engineered products or systems, with a strong understanding of industry regulations and standards.

• Working knowledge of Factory Mutual (FM), ATEX, and CE certification processes and requirements.

• Strong analytical and problem-solving abilities.

• Excellent communication and collaboration skills.

• Proficiency in regulatory software tools and electronic submission processes.

•Detail-oriented with strong technical writing skills

• Willingness to travel occasionally, including international travel if required.