Chemical Regulatory Coordinator
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Job Description
Chemical Regulatory Coordinator supporting the Customer Global Product Stewardship Team by preparing documentation and assessments for medical devices. Responsibilities include toxicology and risk assessments, compiling data, and managing multiple projects.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- Comprehensive benefits program
- Competitive salaries
- Medical, dental vision
- 401K retirement savings plan (100% vested immediately in the employer match)
- Life insurance
- Disability benefits
- Voluntary benefits
- Paid time off for holiday, sick and vacation days
- HSA
- Wellness program
- Flexible spending accounts
- Tuition reimbursement
- Employee Assistance program
- Parental leave
- Optional legal coverage
- ID theft protection
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