Change Control Specialist - Hybrid

We are hiring Change Control Specialist.

Please let me know if you are interested or anyone who might be interested.

Client: Major Medical Device Client

Position: Change Control Specialist

Duration: 18 months on W2

Location: Portage, Michigan 49002

Pay Rate: $35.00-$50.00/ Hr on W2

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Job Description

Work Arrangement: Hybrid

Onsite Requirement: Minimum 2–3 days onsite per week. The first 30 days will require mostly onsite presence for training and shadowing.

Position Summary

We are seeking a Specialist, Change Control & Data Retrieval/Collection to support the Instruments Product Environmental Compliance (PEC) PMO portfolio.

The ideal candidate will be a collaborative partner who can build strong cross-functional relationships to gather, validate, and align data across global teams, suppliers, and systems.

This role requires a detail-oriented problem solver who can navigate complex datasets, trace information across multiple systems, and ensure accuracy and completeness for regulatory compliance.

The successful candidate will thrive in a fast-paced environment, deliver compliant and high-quality outputs, and proactively identify opportunities to improve data availability, quality, collection, and reporting processes.

As the Specialist, Change Control & Data Retrieval/Collection, you will play a critical role in enabling PEC initiatives through structured data gathering, validation, and integration activities.

Key Responsibilities

• Lead data retrieval and collection efforts across internal systems, including PLM, ERP, and QMS, as well as external sources such as suppliers, to support PEC regulatory requirements including REACH, RoHS, PFAS, and PPWR.
• Compile, cleanse, and validate complex datasets to ensure accuracy, traceability, and readiness for regulatory submissions and internal reporting.
• Partner cross-functionally with 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 by 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 into data collection progress, risks, and completion status across PEC programs.
• Contribute to process improvements by standardizing data collection methods, templates, and workflows to improve the efficiency and scalability of PEC efforts.
• May act as Change Owner as needed, coordinating implementation plans and ensuring execution aligns with regulatory timelines.

Required Qualifications

• Bachelor's degree in Engineering or a related field.
• 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 when working with diverse, global teams.
• Strong organizational and project management capabilities.

Preferred Qualifications

• Experience with change control or change management within a regulated industry.
• Experience in the medical device industry.
• Familiarity with Product Environmental Compliance (PEC) regulations, including REACH, RoHS, and PFAS.
• Experience with PLM tools such as Windchill, OnePLM, or similar systems.
• Experience working with supplier data collection and compliance documentation.
• Experience with Change Control, including OnePLM/Windchill.
• Strong supplier communication and coordination experience.

Ideal Candidate Profile

• Collaborative and effective at working across global, cross-functional teams.
• Highly detail-oriented with strong data analysis and problem-solving skills.
• Comfortable working with multiple systems and complex datasets.
• Organized and capable of managing multiple priorities in a fast-paced environment.
• Proactive in identifying data gaps and driving issues toward resolution.
• Strong communicator with experience engaging internal stakeholders and external suppliers.
• Comfortable working in a hybrid environment with a strong onsite presence required during the first 30 days for training and shadowing.

Regards

Vishnu Das Natesan

dvishnu@radiants.com