Regulatory Change & Data Engineer (Medical Devices)

JBL Resources; Portage (MI); On-site; USD 70,000 - 100,000; Full time

Job summary

JBL Resources is seeking a Change Control Engineer in Kalamazoo, MI to drive data-driven regulatory compliance across PEC programs. You will lead data collection from PLM/ERP/QMS, coordinate with suppliers and cross-functional teams, and manage ECNs to ensure audit-ready documentation.

The role focuses on translating regulatory requirements into data needs, performing gap analyses, and improving data collection processes to support timely regulatory submissions and internal reporting.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Ability to gather, analyze, and validate data from multiple sources.
• Strong attention to detail when managing and interpreting complex datasets.
• Excellent communication and collaboration skills across cross-functional teams.
• Strong organizational and project management capabilities.
• Experience with change control or change management in regulated industry.
• Medical device industry experience.
• Familiarity with Product Environmental Compliance regulations, such as REACH, RoHS, or PFAS.
• Experience with PLM tools such as Windchill or onePLM.
• Experience collecting supplier data and managing compliance documentation.

Responsibilities

• Lead data retrieval across internal systems and external suppliers to support PEC regulatory requirements.
• Compile, cleanse, and validate complex datasets for regulatory submissions and internal reporting.
• Partner cross-functionally to obtain material, component, and product-level compliance data.
• Create and manage ECNs within the Quality Management System to implement PEC updates.
• Translate regulatory requirements into data needs and evidence to support compliance initiatives.
• Support supplier engagement and documentation collection for declarations and certifications.
• Perform data analysis and gap assessments; drive resolution with stakeholders.
• Maintain project tracking tools and dashboards for PEC programs.
• Standardize data collection methods and workflows to improve efficiency and scalability.
• Act as Change Owner as needed and coordinate implementation plans.

Skills

Data analysis

Attention to detail

Communication

Project management

Change control

Regulatory knowledge

Medical device experience

Regulatory compliance

Supplier data

Education

Bachelor’s degree in Engineering

Tools

Windchill

onePLM

Job description

JBL Resources is seeking a Change Control Engineer in Kalamazoo, MI to drive data-driven regulatory compliance across PEC programs. You will lead data collection from PLM/ERP/QMS, coordinate with suppliers and cross-functional teams, and manage ECNs to ensure audit-ready documentation.

The role focuses on translating regulatory requirements into data needs, performing gap analyses, and improving data collection processes to support timely regulatory submissions and internal reporting.