Chemical Regulatory Coordinator

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🕒 May 27

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Logo of Pace® Labs

Pace® Labs

1001 - 5000 employees

Environmental Consulting • Pharma/Biopharmaceutical • Medical Device

Pace® Labs is a nationwide network of laboratories and professional services that provides analytical and environmental testing, life‑sciences CDMO/CRO and central laboratory services, building‑science and laboratory support, and emergency response for contamination and outbreak events. The company delivers environmental sampling and testing (air, water, soil, PFAS, Legionella, VOCs, metals, radiochemistry, etc. ), GMP analytical testing and formulation/clinical manufacturing support for pharma and biopharma, medical device testing and regulatory/compliance consulting, plus instrument, cleanroom and facility services to regulated industries.

📋 Description

• 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 • Gap analysis involving cross referencing chemicals against PCTEC, CHS, and hazard summary data. Comparing the quality of data across all three sources.

🎯 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 and have excellent written and verbal communication skills • Must have the ability to manage multiple projects simultaneously

🏖️ Benefits

• comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and 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 and ID theft

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