Change Control Specialist (PEC Regulatory)

iMPact Business Group; Portage (MI); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Impact Business Group seeks a Change Control Specialist for an 18-month contract in a hybrid role in Portage, MI. The candidate will lead data retrieval across PLM, ERP, and QMS to support PEC regulatory requirements, while ensuring data accuracy and audit readiness.

Responsibilities include compiling datasets, coordinating with Engineering, Regulatory, and Supply Chain, and managing ECNs to implement PEC findings within compliant timelines.

Qualifications

• Experience retrieving and validating complex data for regulatory submissions.
• Ability to work across Engineering, Regulatory and Supply Chain with accuracy.
• Detail-oriented problem solving in fast-paced PEC environments.

Responsibilities

• Lead data retrieval across internal systems (PLM, ERP, QMS) and external sources to support PEC requirements.
• Compile, cleanse, and validate datasets for regulatory submissions and reporting.
• Create and manage ECNs within QMS and coordinate with suppliers and cross-functional teams.

Skills

Data retrieval

Cross-functional collaboration

Regulatory compliance

Data analysis

Process improvement

Tools

PLM

ERP

QMS

Job description

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Change Control Specialistfor 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.