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Compliance Engineer

Role overview

Qualifications

  • Strong knowledge of regulatory standards and certifications (e.g., UL, EU MDR, REACH SVHC, RoHS, WEEE, Prop 65, FSSC, Conflict Minerals) and related materials regulatory requirements
  • Experience establishing and maintaining centralized regulatory statements repositories and managing regulatory compliance documentation
  • Ability to develop and communicate technical and administrative guidance to project teams to obtain regulatory certifications and meet domestic/global regulations
  • Experience in risk management and product stewardship, with collaboration across Product Stewardship and Regulatory (PSR) organizations

Responsibilities

  • Establish and maintain a centralized material regulatory statements repository across the Spectrum enterprise to support assessment and records management and respond to customer inquiries
  • Develop and communicate clear technical and administrative guidance to project teams for regulatory certifications and compliance with domestic and global regulations
  • Maintain compliance statuses of Spectrum materials with existing, new, or amended regulations
  • Guide project teams to ensure design systems fulfill customer expectations and site materials-related regulatory compliance; manage materials-related sites compliance requirements and reporting obligations

About the company

Spectrum Plastics Group, A DuPont Business logo

Spectrum Plastics Group, A DuPont Business

Contract Development & Manufacturing Organizations (CDMO)

Acquired in August 2023 by DuPont, Spectrum’s history spans over 60 years of applications expertise including precision extrusion, specialty injection molding, blown film extrusion and conversion, medical balloon fabrication, laser processing, additive manufacturing, and complex assembly of catheters and other devices. Today, Spectrum is a leading full-service partner for the development and manufacturing of critical polymer-based components and finished devices for medical and other demanding applications. With 19 locations and more than 1 million square feet of manufacturing space in six countries worldwide, we have the resources to solve customers’ most challenging problems with proven quality, responsiveness, innovation and technical expertise.

Company details

IndustryContract Development & Manufacturing Organizations (CDMO)
Company size1001 - 5000

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Job description

SUMMARY: As part of the Quality organization, the Compliance Engineer will provide support  to Spectrum sites and its customers through leadership in materials documentation for certifications  (such as UL, EU MDR, REACH SVHC, RoHS, WEEE, Conflict  minerals, Cal Prop 65, FSSC, etc.),  regulatory compliance, and risk management  in alignment with DuPont Product Stewardship practices and Regulatory compliance processes.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

In collaboration with the Product Stewardship and Regulatory (PS&R) organization,

  • Establish and maintain a centralized material regulatory statements repository across the Spectrum enterprise to support the assessment and records management of materials regulatory compliance as well as customer inquiries response process.
  • Develop and communicate clear technical and administrative guidance to project teams in support of obtaining regulatory certifications and meeting relevant domestic & global regulations.
  • Maintain compliance statuses of Spectrum business materials with existing, new or amended regulations.
  • Manage and maintain materials-related sites compliance requirements and reporting obligations.
  • Guide project teams to ensure that design systems fulfil customer expectations and site materials-related regulatory compliance.
  • Streamline and manage regulatory-related customer inquiries response process.
  • Serve as a focal point to and coordinate site responses for the PS&R organization.
  • Collaborate with PS&R to develop responses for any corporate-driven risk and regulatory compliance management:
    • Provide in-depth regulatory/technical expertise to manage regulatory or product stewardship driven analyses; identify improvement opportunities
    • Support the integration of Spectrum into the PS&R management system from a risk management perspective.
  • Review of existing documents (procedures, work instructions, etc.) for accuracy, robustness, and compliance

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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