Associate Regulatory Data & Change Control Specialist

System One, Inc.; Portage (MI); Hybride; USD 48 000 - 68 000; Temps partiel

Résumé du poste

System One, Inc. is seeking an Associate Change Control & Data Retrieval Specialist in Portage, MI. This contract role combines hybrid work arrangements with onsite and remote duties to support PEC regulatory requirements and data-driven compliance initiatives.

You will lead data retrieval across PLM/ERP/QMS, validate complex datasets, and coordinate with Engineering, Supply Chain, Regulatory, and Quality teams. Experience with PEC regulations and PLM tools is preferred.

Qualifications

• Bachelor’s degree in Engineering or related field is required.
• Strong attention to detail and ability to manage complex datasets.
• Experience gathering, analyzing, and validating data from multiple sources.
• Excellent communication and collaboration across global teams.

Responsabilités

• Lead data retrieval across internal systems (PLM, ERP, QMS) and external sources to support PEC regulatory requirements.
• Compile, cleanse, and validate datasets for regulatory submissions and internal reporting.
• Create and manage ECNs within the Quality Management System to implement PEC findings.
• Translate regulatory requirements into data needs and evidence.
• Support supplier engagement to obtain material declarations and compliance docs.
• Maintain and update project tracking tools and dashboards for PEC programs.

Connaissances

Attention to detail

Data analysis

Cross-functional collaboration

Regulatory knowledge

Project management

Communication

Formation

Bachelor's degree in Engineering or related field

Outils

Windchill / onePLM

PLM tools

Description du poste

System One, Inc. is seeking an Associate Change Control & Data Retrieval Specialist in Portage, MI. This contract role combines hybrid work arrangements with onsite and remote duties to support PEC regulatory requirements and data-driven compliance initiatives.

You will lead data retrieval across PLM/ERP/QMS, validate complex datasets, and coordinate with Engineering, Supply Chain, Regulatory, and Quality teams. Experience with PEC regulations and PLM tools is preferred.