Chemical Regulatory Coordinator

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Assist the Customer Global Product Stewardship Team by reviewing, organizing, and summarizing documents while preparing reports and assessments.

• Execute toxicology and risk assessments related to medical devices and manufacturing processes.

• Create Chemical Hazard Summaries and Biological Evaluation Reports, which include data tables and literature reviews.

• Compile and summarize biocompatibility test data and study findings.

• Conduct qualitative toxicology assessments utilizing existing data, regulatory classifications, and scientific literature.

• Perform gap analysis by cross-referencing chemicals against PCTEC, CHS, and hazard summary data, while evaluating the quality of data across all three sources.

⛳️ Requirements

• A Bachelor’s degree in Chemistry, Biochemistry, Biology, or a related scientific field.

• A minimum of 2 years of experience in document preparation, archiving, or storage is preferred.

• Previous experience with SAP, PLM, Hardgoods document storage workspace, providing administrative support, and facilitating communication between the Product Compliance Engineer and Test Houses, as well as updating product safety test reports and NPI/CMP support is ideal.

• Strong problem-solving abilities along with excellent written and verbal communication skills are necessary.

• Must be capable of managing multiple projects concurrently.

🏝️ Benefits

• Comprehensive benefits program including competitive salaries, medical, dental, and vision coverage, a 401K retirement savings plan (100% vested immediately in the employer match), life insurance, disability, and voluntary benefits.

• Paid time off for holidays, sick leave, and vacation days, along with HSA, wellness programs, flexible spending accounts, tuition reimbursement, an Employee Assistance program, parental leave, optional legal coverage, and identity theft protection.