Regulatory Compliance Data Specialist-27500

Job Description

Job Description

Our client, a global medical device manufacturer, is seeking a  Regulatory Compliance Data Specialist for a 12 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 & Data Retrieval/Collection Specialist will support our client and their Medical Instruments Product Environmental Compliance (PEC) PMO portfolio. This hybrid role is based in Kalamazoo, Michigan.

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.

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

Qualifications

• Bachelor's degree in Engineering or a related field (with engineering mindset preferred).
• 1-3 years of relevant experience in change management, data analysis, or compliance support in a regulated environment.
• Exceptional attention to detail with the ability to interpret and manage complex datasets across systems (PLM, ERP, QMS).
• Proven experience gathering, analyzing, and validating data from multiple sources.
• Excellent communication and collaboration skills, comfortable working with global teams and suppliers.
• Strong organizational and project management skills with the ability to prioritize and manage multiple projects.
• Adaptability and initiative in a changing environment.
• 1-3 years of change management or related experience, preferably within a regulated industry.
• Experience working with supply bases and compliance documentation.
• Experience in change control or change management within regulated industries, especially medical devices.
• Familiarity with Product Environmental Compliance (PEC) regulations (REACH, RoHS, PFAS).
• Knowledge of PLM tools such as Windchill or onePLM.
• Exposure to supplier data collection and compliance processes.
• Awareness of broader environmental standards and regulations in manufacturing.

Company Description

Whether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management.

Benefits:
401(k)
Comprehensive dental, vision, and health insurance
Life insurance
Professional development assistance

iMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential.

Experience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference!

Company Description

Whether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management.\r\n\r\nBenefits:\r\n401(k) \r\nComprehensive dental, vision, and health insurance\r\nLife insurance\r\nProfessional development assistance\r\n\r\n\r\niMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential. \r\n\r\nExperience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference!