Regulatory Compliance Data Specialist

Regulatory Compliance Data Specialist

Our client, a global medical device manufacturer, is seeking a Regulatory Compliance Data Specialist for a 12 Month + Contract. You will have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment. The Change Control & Data Retrieval/Collection Specialist will support our client and their Medical Instruments Product Environmental Compliance (PEC) PMO portfolio.

This hybrid role is based in Kalamazoo, Michigan.

WHO WE WANT

• Collaborative partners:
  Individuals who build strong cross-functional relationships to gather, validate, and align data across global teams, suppliers, and systems.
• Detail-oriented problem solvers:
  Professionals who can navigate complex datasets, trace information across multiple systems, and ensure accuracy and completeness for regulatory compliance.
• Goal-oriented achievers:
  Individuals who thrive in fast-paced environments and are focused on delivering compliant, high-quality outputs aligned to evolving PEC requirements.
• Continuous improvement drivers:
  People who proactively identify gaps in data availability, quality, and processes, and work to enhance data collection and reporting mechanisms.

Key Responsibilities

• Leading data retrieval and collection efforts across internal systems (e.g., PLM, ERP, QMS) and external sources (e.g., suppliers) to support PEC regulatory requirements.
• Compiling, cleansing, and validating complex datasets to ensure accuracy, traceability, and readiness for regulatory submissions and internal reporting.
• Partnering cross-functionally with Engineering, Supply Chain, Regulatory, Quality, and external suppliers to obtain required material, component, and product-level compliance data.
• Creating and managing Enterprise Change Notices (ECNs) within the Quality Management System to implement updates tied to PEC findings, ensuring all documentation and data inputs are compliant and audit-ready.
• Translating regulatory requirements into clear data needs by identifying required attributes, documentation, and evidence to support compliance initiatives.
• Supporting supplier engagement and outreach by requesting, tracking, and following up on material declarations, certifications, and compliance documentation.
• Performing data analysis and conducting gap assessments, highlighting missing or inconsistent information and driving resolution with stakeholders.
• Maintaining and updating project tracking tools and dashboards to ensure visibility of data collection progress, risks, and completion status across PEC programs.
• Contributing to process improvements by standardizing data collection methods, templates, and workflows to enhance efficiency and scalability of PEC efforts.
• Acting as Change Owner when needed, coordinating implementation plans and ensuring execution aligns with regulatory timelines.

Job Requirements

• Bachelor's degree in Engineering or a related field (with engineering mindset preferred).
• 1-3 years of relevant experience in change management, data analysis, or compliance support in a regulated environment.
• Exceptional attention to detail with the ability to interpret and manage complex datasets across systems (PLM, ERP, QMS).
• Proven experience gathering, analyzing, and validating data from multiple sources.
• Excellent communication and collaboration skills, comfortable working with global teams and suppliers.
• Strong organizational and project management skills with the ability to prioritize and manage multiple projects.
• Adaptability and initiative in a changing environment.
• 1-3 years of change management or related experience, preferably within a regulated industry.
• Experience working with supply bases and compliance documentation.
• Experience in change control or change management within regulated industries, especially medical devices.
• Familiarity with Product Environmental Compliance (PEC) regulations (REACH, RoHS, PFAS).
• Knowledge of PLM tools such as Windchill or onePLM.
• Exposure to supplier data collection and compliance processes.
• Awareness of broader environmental standards and regulations in manufacturing.

About Portage, MI

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