Regulatory Affairs Engineer

The function of the Regulatory Affairs Engineer will be to monitor, influence, and analyze business and regulatory systems and document control.  Manage regulatory events and legislation across a wide geographic region that impact or has potential effect on the Company’s business and interests.  Coordinate, prepare, evaluate, issue and audit product to world wide regulatory specifications including but not limited to CE, CSA, UL, ETL, KIWA, EN1717, RoHS and others.  Refine Engineering business systems in BOM creation, prototype accounting, ECR/EO generation and processing.

ESSENTIAL FUNCTIONS:

· Implement regulatory strategies with Engineering, Operations, Sales and Marketing.

· Interface with external regulatory bodies in response to communications received as well as facilitate required inspections of audits.

· Provide regulatory guidance and opinion as well as assist in the assembly of pertinent data/reports and preparations to submissions.

· Prepare and submit necessary documentation to support international regulatory submissions required.

· Determine areas of regulatory risk and propose and implement strategies to reduce risk.

· Coordinate and lead internal audits for compliance with regulatory standards.

· Work with Engineering and Purchasing to ensure integrity of product compliance with the facilitation of global cost reduction programs.

· Refine and implement new business systems within Engineering department to better process BOMs, Drawings, Costing, Prototype Builds and Project Management.

· Work with Document Control Manager to issue, log, and file EO’s of new products and changes to existing products.

· Track and Manage Customer Quality Complaint system for engineering department.

MINIMUM QUALIFICATIONS & SPECIALIZED KNOWLEDGE:

·BS Degree in a technical field required.

· 5+ years Business Systems experience, document control and regulatory affairs.

· Knowledge of CE, CSA, UL, ETL, KIWA, EN1717 and RoHS a plus.

· Six-Sigma, VSM, JD Edwards experience a plus.

 

You are eligible for benefits including medical, dental, holidays, and matching 401(k) plans on your date of hire.

 

Please send resume and salary requirements to hr.knight@idexcorp.com

 

www.knightequip.com

www.idexcorp.com