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Regulatory Specialist

Date:  Nov 18, 2022
Location: 

Franklin, PA, US, 16323

Req ID:  25672
Onsite or Remote:  Partial Remote Position

Komatsu is an indispensable partner to the construction, mining, forestry, forklift, and industrial machinery markets, maximizing value for customers through innovative solutions. With a diverse line of products supported by our advanced IoT technologies, regional distribution channels, and a global service network, we tap into the power of data and technology to enhance safety and productivity while optimizing performance. Komatsu supports a myriad of markets, including housing, infrastructure, water, pipeline, minerals, automobile, aerospace, electronics and medical, through its many brands and subsidiaries, including TimberPro, Joy, P&H, Montabert, Modular Mining Systems, Hensley Industries, NTC, and Gigaphoton.

Job Overview

Major Responsibilities / Key End Results / Purpose of Position:

Lead regulatory projects to develop, maintain and support components, products, systems and/or services per market demands as well as for continuous improvement.

Plan and lead regulatory evaluations including investigations, performing fundamental calculations and tests with well-defined requirements and desired outcomes.

Provide conceptual, strategic, practical and tactical solutions, as appropriate, to solve problems that are associated with regulatory projects or evaluations.

Take responsibility for one's own learning and development for the mutual benefit of one's self and the organization.

Lead, coach, and/or act as consultant to those who are designing/redesigning components, products and systems with regulatory requirements. 

Lead and support programs for effective communication of regulatory issues to ensure compliance with global standards for design and safety of components, products, systems and services.

Develop and lead continuous improvement to regulatory compliance processes used to design, develop, maintain, manufacture and support components, products, and/or services.

Participate in effective Change Management to achieve the desired organizational outcomes by successfully changing behaviors as needed.

Key Job Responsibilities

Predominant Tasks

  1. Manage projects to obtain appropriate certification and/or regulatory approvals
  2. Supervise groups in performance of specific projects
  3. Plan and supervise reviews of current designs for regulatory compliance and participate in engineering regulatory compliance reviews for new products.
  4. Support the review and resolution of deviation requests and drawing change requests for assurance of continued regulatory compliance.
  5. Support the investigation of regulatory compliance incidents and work with appropriate parties to develop corrective actions, as appropriate.
  6. Meet with suppliers concerning changes to, or new requirements for, their products.
  7. Direct, develop or specify regulatory test programs for certification of products. 
  8. Meet with Global and Regional regulatory and standards bodies to stay abreast of changes to existing or to new regulations and address their impact upon our customers and designs.  Disseminate information across the corporation.
  9. Support Quality audits of suppliers, manufacturing sites and machines. 
  10. Review customer orders to determine the need for new regulatory projects and schedule accordingly.
  11. Review and approve engineering records for regulatory/certification compliance prior to release.
  12. Develop and lead continuous improvement projects for regulatory compliance processes.

Qualifications/Requirements

Background

Technology Degree in Engineering, Business or equivalent relevant discipline, required.

8 years’ experience in design, machine application, mining industry, desired.

6 years’ experience in regulatory compliance desired

Experience in the use of computer-aided design (CAD) tools desired.

Participation in implementing Lean Engineering principles desired.

Participation in effective Change Management implementation highly desired.

Experience in cross-functional team assignment(s) highly desired.

Certifications or demonstrated project management experience required.

Professional registration and/or membership in committees and/or technical societies, beneficial.

 

Additional Information

Komatsu is an Equal Opportunity Workplace and an Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.


Nearest Major Market: Erie

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