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Regulatory Compliance Data Specialist
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.
Job Requirements
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.
Contract positions
Will be employed and paid hourly by iMPact Business Group. Benefits (medical, dental & vision) are available after 90 days of employment.
Permanent placed employees
Paid by and qualify for benefits in accordance with the policies of the hiring company.
Submit your resume today to be considered for this position. A recruiter will review within a business day or two and will reach back out to you if they would like to discuss next steps.
Internal Positions
We have several internal positions at iMPact that we are hiring for. Please view our internal positions here.
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