Regulatory Data & Change Control Specialist

Required Education:

• Bachelor’s Degree

Required Skills:

• 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.
• Strong attention to detail with the 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.

Preferred Skills:

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

Regulatory Data & Change Control Specialist:

• Lead data retrieval and collection efforts across internal systems (e.g., PLM, ERP, QMS) and external sources (e.g., suppliers) to support PEC regulatory requirements (e.g., REACH, RoHS, PFAS, PPWR).
• Compile, cleanse, and validate complex datasets to ensure accuracy, traceability, and readiness for regulatory submissions and internal reporting.
• Partner cross-functionally (Engineering, Supply Chain, Regulatory, Quality, and external suppliers) to obtain required 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 all documentation and data inputs are compliant and audit-ready.
• Translate regulatory requirements into data needs, identifying required attributes, documentation, and evidence to support compliance initiatives.
• Support supplier engagement and outreach to request, track, and follow up on material declarations, certifications, and compliance documentation.
• Perform data analysis and gap assessments, highlighting missing or inconsistent information and driving resolution with stakeholders.
• Maintain and update project tracking tools and dashboards, ensuring visibility to 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 and scalability of PEC efforts.
• May act as Change Owner as needed, coordinating implementation plans and ensuring execution aligns with regulatory timelines.