Support the Customer Global Product Stewardship Team by reviewing, organizing, and summarizing documents, and preparing reports and assessments
Conduct toxicology and risk assessments for medical devices and manufacturing processes
Prepare Chemical Hazard Summaries and Biological Evaluation Reports, including data tables and literature reviews
Compile and summarize biocompatibility test data and study results
Perform qualitative toxicology assessments using existing data, regulatory classifications, and scientific literature
Conduct gap analysis involving cross-referencing chemicals against PCTEC, CHS, and hazard summary data

Bachelor’s degree in Chemistry, Biochemistry, Biology, or related science
2 years of experience in document preparation, archiving, or storage is preferred
Prior experience with SAP, PLM, Hardgoods document storage workspace, admin support, contact support between Product Compliance Engineer and Test Houses, updating product safety test reports and NPI/CMP support is ideal
Possess problem solving skills
Excellent written and verbal communication skills
Must have the ability to manage multiple projects simultaneously

Chemical Regulatory Coordinator

Key skills