Change Control Analyst

This hybrid role supports the Instruments Product Environmental Compliance (PEC) portfolio by leading structured data retrieval, collection, and change control activities. The Specialist, Change Control & Data Retrieval/Collection builds strong cross-functional relationships, gathers and validates complex data from internal systems and external suppliers, and ensures that product information is accurate, traceable, and ready for regulatory submissions and internal reporting. The position focuses on enabling compliance with key PEC regulations such as REACH, RoHS, PFAS, and PPWR while continuously improving data collection processes and tools. Responsibilities

• Lead data retrieval and collection efforts across internal systems such as PLM, ERP, and Quality Management Systems, as well as from external suppliers, to support Product Environmental Compliance (PEC) regulatory requirements including REACH, RoHS, PFAS, and PPWR.
• Compile, cleanse, and validate complex datasets to ensure accuracy, traceability, and readiness for regulatory submissions and internal reporting.
• Partner cross-functionally 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 tied to PEC findings, ensuring documentation and data inputs are compliant and audit-ready.
• Translate regulatory requirements into clear data needs by identifying required attributes, documentation, and evidence to support compliance initiatives.
• Support supplier engagement and outreach by requesting, tracking, and following up on material declarations, certifications, and compliance documentation.
• Perform data analysis and gap assessments to identify missing, inconsistent, or incomplete information and drive resolution with stakeholders.
• Maintain and update project tracking tools and dashboards to provide visibility into data collection progress, risks, and completion status across PEC programs.
• Contribute to process improvements by standardizing data collection methods, templates, and workflows to enhance efficiency, consistency, and scalability of PEC efforts.
• Act as Change Owner when needed, coordinating implementation plans and ensuring execution aligns with regulatory timelines and project milestones.
• Build and maintain strong cross-functional and global relationships to gather, validate, and align data across teams, suppliers, and systems.
• Proactively identify gaps in data availability, quality, and processes, and recommend enhancements to improve data integrity and reporting.

• Bachelors degree in Engineering or a related field.
• Experience with engineering change management, including engineering change orders and engineering change processes.
• Experience working with or supporting medical device products or in a medical device environment.
• Hands-on experience with data retrieval and management using PLM, ERP, and Quality Management Systems.
• Strong attention to detail with the ability to manage, interpret, and verify complex datasets.
• Demonstrated ability to gather, analyze, and validate data from multiple internal and external sources.
• Excellent communication and collaboration skills with diverse, global teams.
• Strong organizational and project management capabilities to manage multiple tasks and deadlines effectively.

Additional Skills & Qualifications

• Experience in change control or change management within a regulated industry.
• Experience in the medical device industry, including familiarity with regulated quality systems and documentation practices.
• Familiarity with Product Environmental Compliance (PEC) regulations such as REACH, RoHS, and PFAS.
• Experience with PLM tools such as Windchill, onePLM, or similar systems.
• Experience working with supplier data collection, including material declarations, certifications, and compliance documentation.
• Ability to thrive in a fast-paced environment while delivering compliant, high-quality outputs aligned to evolving PEC requirements.
• A continuous improvement mindset with the ability to identify and implement enhancements to data collection and reporting processes., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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