Regulatory Compliance & Change Control Specialist

Company is seeking to hire a Specialist, Change Control & Data Retrieval/Collection to support the 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.

WHAT YOU WILL DO
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. You will:
Lead 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).
Compile, cleanse, and validate complex datasets to ensure accuracy, traceability, and readiness for regulatory submissions and internal reporting.
Partner cross-functionally (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, 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 to data collection progress, risks, and completion status across PEC programs.
Contribute to process improvements by standardizing data collection methods, templates, and workflows to enhance efficiency and scalability of PEC efforts.
May act as Change Owner as needed, coordinating implementation plans and ensuring execution aligns with regulatory timelines.

WHAT YOU NEED
Required:
Bachelor's degree in Engineering or 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 across diverse, global teams
Strong organizational and project management capabilities

Preferred:
Experience in change control or change management within a regulated industry
Experience in the medical device industry
Familiarity with Product Environmental Compliance (PEC) regulations (e.g., REACH, RoHS, PFAS)
Experience with PLM tools (Windchill/onePLM) or similar systems
Experience working with supplier data collection and compliance documentation

Work schedule:
- Hybrid position, initial training will require more onsite time but hybrid schedule will be set based on contingent performance (typically 2-4 days onsite weekly)
- Working Eastern Time Zone hours
- Some flexibility with 8 or 9 start time
- Possibility for OT but typically 40 hours weekly
- Targeting 8/10 start date

Must haves:
- Candidate must be adaptable (working in an ever-changing environment) and have ability to take initiative
- Candidate must have strong communication and collaboration skills, will be working with internal company teams
- Candidate must have strong time management skills and ability to make decisions on how they work independently. Candidate will be supporting multiple projects
- 1-3 years of change management experience
- Experience dealing with a supply base

Nice to haves:
- Medical device industry experience
- Awareness/knowledge of Product Environmental Compliance (PEC)

Education:
Preference for a Bachelor's degree in Engineering or related field (engineering mindset seems to align best but open to any candidate with higher level education)