Change Control Specialist (PEC Regulatory)

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Change Control Specialist for a 18 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also 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 Specialist will support Retrieval/Collection to support the our clients Medical Instruments Product Environmental Compliance (PEC) PMO portfolio. Hybrid role with min 2-3 days onsite - FIRST 30 DAYS WILL NEED TO BE MOSTLY ONSITE FOR TRAINING/SHADOWING

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.

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 (e.g., REACH, RoHS, PFAS, PPWR).
• 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 while ensuring all documentation and data inputs are compliant and audit-ready.
• Translating regulatory requirements into data needs and 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 gap assessments, highlighting missing or inconsistent information, and driving resolution with stakeholders.
• Maintaining and updating project tracking tools and dashboards to ensure visibility into data collection progress, risks, and completion status across PEC programs.
• Contributing to process improvements by standardizing data collection methods, templates, and workflows to enhance the efficiency and scalability of PEC efforts.
• Acting as Change Owner as needed, coordinating implementation plans, and ensuring execution aligns with regulatory timelines.

Qualifications

• Bachelor's degree in Engineering or a related field.
• Ability to gather, analyze, and validate data from multiple sources.
• Strong attention to detail when managing and interpreting complex datasets.
• Excellent communication and collaboration skills across cross-functional teams.
• Strong organizational and project management capabilities.
• Experience with change control or change management in a regulated industry.
• Medical device industry experience.
• Familiarity with Product Environmental Compliance regulations, such as REACH, RoHS, or PFAS.
• Experience with PLM tools such as Windchill or onePLM.
• Experience collecting supplier data and managing compliance documentation.