Location: Kalamazoo, MI
Work Arrangement: Hybrid
Field: Engineering
We’re actively seeking qualified candidates for a Specialist, Change Control & Data Retrieval/Collection to support product environmental compliance initiatives within a regulated medical device environment.
What You’ll Do
- Retrieve and collect data from internal systems (PLM, ERP, QMS) and external suppliers to support regulatory requirements, including REACH, RoHS, PFAS, and PPWR.
- Compile, clean, and validate complex datasets to ensure accuracy, traceability, and compliance readiness.
- Collaborate with Engineering, Supply Chain, Regulatory, Quality, and suppliers to obtain material, component, and product compliance data.
- Create and manage Enterprise Change Notices (ECNs) within a Quality Management System (QMS), ensuring documentation is accurate and audit-ready.
- Translate regulatory requirements into data collection needs, documentation, and supporting evidence.
- Coordinate supplier outreach and track material declarations, certifications, and compliance documentation.
- Perform data gap assessments, resolve inconsistencies, and track project progress, risks, and completion status.
- Maintain project dashboards and tracking tools while identifying opportunities to improve data collection processes and workflows.
- Support change implementation plans and ensure alignment with regulatory timelines.
Required Qualifications
- Bachelor’s degree in Engineering or a related field.
- Strong attention to detail and the ability to manage and interpret complex datasets.
- Experience gathering, analyzing, and validating data from multiple sources.
- Excellent communication and collaboration skills when working with cross-functional and global teams.
- Strong organizational and project management skills.
Preferred Qualifications
- Experience with change control or change management in a regulated industry.
- Medical device industry experience.
- Familiarity with Product Environmental Compliance (PEC) regulations, including REACH, RoHS, and PFAS.
- Experience with PLM systems such as Windchill or onePLM, or similar platforms.
- Experience with supplier data collection and regulatory compliance documentation.
Who Will Succeed in This Role?
We’re looking for a detail-oriented, collaborative professional who can navigate complex data systems, identify information gaps, coordinate across global teams, and help ensure environmental compliance requirements are met accurately and efficiently.