About The Position

The Specialist, Change Control & Data Retrieval/Collection supports the Instruments Product Environmental Compliance (PEC) PMO portfolio. This hybrid role is based in Kalamazoo, Michigan and enables PEC initiatives through structured data gathering, validation, and integration. The specialist collects and validates information from internal systems and external sources, works with cross-functional teams and suppliers, and ensures data is accurate, traceable, and ready for regulatory submissions and internal reporting. The role also manages Enterprise Change Notices related to PEC findings, supports supplier outreach, assesses data gaps, maintains project tracking tools, and contributes to improvements in data collection processes.

Requirements

  • Bachelor’s degree in Engineering or a related field.
  • Strong attention to detail and ability to manage and interpret complex datasets.
  • Demonstrated ability to gather, analyze, and validate data from multiple sources.
  • Excellent communication and collaboration skills across diverse, global teams.
  • Strong organizational and project management capabilities.

Nice To Haves

  • Experience in change control or change management within a regulated industry.
  • Experience in the medical device industry.
  • Familiarity with Product Environmental Compliance (PEC) regulations such as REACH, RoHS, and PFAS.
  • Experience with PLM tools such as Windchill or onePLM, or similar systems.
  • Experience working with supplier data collection and compliance documentation.

Responsibilities

  • Lead data retrieval and collection across internal systems such as PLM, ERP, and QMS, as well as external sources such as suppliers, to support PEC regulatory requirements including REACH, RoHS, PFAS, and PPWR.
  • Compile, cleanse, and validate datasets to ensure accuracy, traceability, and readiness for regulatory submissions and internal reporting.
  • Partner with Engineering, Supply Chain, Regulatory, Quality, and external suppliers to obtain material-, component-, and product-level compliance data.
  • Create and manage Enterprise Change Notices (ECNs) within the Quality Management System to implement updates related to PEC findings and ensure documentation and data inputs are compliant and audit-ready.
  • Translate regulatory requirements into data needs, identifying required attributes, documentation, and evidence.
  • Support supplier engagement and outreach to request, track, and follow up on material declarations, certifications, and compliance documentation.
  • Perform data analysis and gap assessments, identify missing or inconsistent information, and drive resolution with stakeholders.
  • Maintain and update project tracking tools and dashboards to provide visibility into PEC program data-collection progress, risks, and completion status.
  • Contribute to process improvements by standardizing data collection methods, templates, and workflows.
  • May act as Change Owner, coordinating implementation plans and ensuring execution aligns with regulatory timelines.
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