Regulatory Operations Lead - Engineering

Position Summary

The Regulatory Operations Lead owns execution, coordination and visibility of regulatory activities across products and manufacturing sites. This role ensures regulatory work is scheduled, tracked and delivered on time – enabling regulatory engineers to focus on standards interpretation and technical decision-making while reducing risk to product launches and manufacturing continuity.

Key Responsibilities

The position owns the operational execution and visibility of regulatory activities across IEM products and manufacturing sites. Key responsibilities include:

• Own the planning, coordination and execution of regulatory activities, including certifications, approvals and field inspection workflows, based on technical direction provided by regulatory engineersDevelop, maintain and manage regulatory schedules, milestones, dependencies and deliverables across multiple concurrent initiatives


• Serve as the primary intake and coordination point for engineering, manufacturing, supplier, and material changes requiring regulatory review, ensuring requests are properly scoped, tracked, and routed.


• Coordinate regulatory impact assessments with Regulatory Engineers and other technical leads, ensuring outcomes, conditions, and required actions are documented and followed through.


• Track regulatory risks, conditions, deviations, renewals, and commitments; proactively escalate execution or schedule risks to leadership.


• Maintain accurate regulatory status, documentation workflows, and traceability across products and sites, and continuously improve processes, tools, and templates to support organizational scale.

Competencies

• Strong operational ownership mindset with demonstrated ability to drive execution without owning technical decision-making.


• Excellent planning, organization, and prioritization skills across multiple concurrent workstreams.


• Ability to translate regulatory needs and technical inputs into clear timelines, expectations, and deliverables.


• Proven effectiveness coordinating across engineering, manufacturing, quality, program, and external partner teams.


• Comfort working in regulated environments with high documentation, traceability, and audit expectations.


• Clear, confident communicator with both technical and non-technical stakeholders.


• Process-oriented thinker with the ability to design, improve, and scale workflows and governance.


• Proficiency with common tracking, documentation, and reporting tools; experience building Dashboards or visual status reporting is a plus.


• Clear, confident communicator across technical and non-technical teams

Education and Experience

• Bachelor’s degree in engineering, Industrial Engineering, Operations Management, Supply Chain, Business, or a related field, or equivalent experience in regulatory operations, compliance execution, or technical program management.


• 5–8+ years of progressive experience owning regulatory operations, compliance execution or technical program management in a regulated environment.


• Experience coordinating work across engineering, manufacturing, quality, and external partners.


• Experience working with certification bodies, test laboratories, or regulatory partners in an operational or coordination capacity is strongly preferred.


• Experience supporting multi-site manufacturing operations or complex product portfolios is a plus.


• Familiarity with product testing and certification processes in the electrical manufacturing industry preferred; responsibility for technical standards interpretation is not required.

Compensation

The salary range for this role is $82,560 - $104,000 per year, based on location, experience, and qualifications.