Change Control & Data Retrieval Specialist

Actalent; Portage (MI); Hybrid; USD 48,000 - 68,000; Full time

Benefits offered by this job

Health, dental & vision coverage

401(k) retirement plan

Job summary

Actalent seeks a Specialist, Change Control & Data Retrieval/Collection, hybrid from Portage, MI, to lead data gathering across PLM/ERP/QMS and external suppliers for PEC regulatory needs (REACH, RoHS, PFAS, PPWR). You will validate datasets, manage ECNs, and drive data quality and audit readiness in a regulated environment.

The role emphasizes cross-functional collaboration with Engineering, Regulatory, Quality, and Supply Chain, leveraging Windchill/onePLM and ERP systems, with a focus on

Qualifications

• 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.

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.

Skills

Change management

Medical devices

Data retrieval

Attention to detail

Data sources

Cross-functional communication

Project management

Education

Bachelors degree in Engineering

Tools

Windchill

onePLM

Job description

Actalent seeks a Specialist, Change Control & Data Retrieval/Collection, hybrid from Portage, MI, to lead data gathering across PLM/ERP/QMS and external suppliers for PEC regulatory needs (REACH, RoHS, PFAS, PPWR). You will validate datasets, manage ECNs, and drive data quality and audit readiness in a regulated environment.

The role emphasizes cross-functional collaboration with Engineering, Regulatory, Quality, and Supply Chain, leveraging Windchill/onePLM and ERP systems, with a focus on