Jiaru Zhang, M.P.H., DABT
Principal Scientist
Ms. Zhang is a principal scientist and toxicologist specializing in per- and polyfluoroalkyl substances (PFAS) compliance, medical device safety evaluations, alternatives assessment, and regulatory compliance for industrial and consumer products. She has led large, multi- functional teams through PFAS reporting, Toxic Substances Control Act (TSCA) compliance, thousands of hazard evaluations, and new chemical registrations. For alternatives assessment, Ms. Zhang has led multiple safer-chemistry initiatives, helping companies to identify safer alternatives, refine formulations, and meet evolving regulatory requirements. In addition, she successfully supports medical device approvals by producing robust biocompatibility safety evaluations and toxicological risk assessments using extractable datasets that stand up to regulatory scrutiny. Prior to joining Gradient, Ms. Zhang worked at the Fox Chase Cancer Center and at the United Nations Convention of Long-Range Transboundary Air Pollution.
PFAS Reporting: Led a major PFAS compliance program for a global commercial vehicle manufacturer, covering US (TSCA), Canada (CEPA), and multiple US state mandates. Designed jurisdiction-specific supplier surveys for tens of thousands of products, built a secure web-based data platform, and delivered complete regulatory submissions and audit-ready documentation. Leveraged advanced outreach tools and a custom supplier portal to transform a highly complex reporting effort into a streamlined, scalable process.
Medical Device Biocompatibility Approval: For a variety of devices, developed customized testing strategies and provided consulting support throughout the entire biological evaluation process to support compliance with the requirements of ISO 10993/18562, US FDA, and EU Medical Device Regulation (EU MDR). Leveraging existing data whenever possible, produced gap assessments and biological evaluation plans/reports that attributed to successful device approvals.
Medical Device Toxicological Risk Assessment: For a variety of devices and in accordance with ISO 10993-17 and US FDA guidance, identified toxicological data for relevant endpoints and derived chemical- and device-specific safety margins. For data gaps, identified robust read-across and used state-of-the-art modeling programs to assess potential hazards. For large datasets, identified efficient and defensible approaches to narrow the scope, and produced clinically relevant toxicological risk assessments. Generated reports that assisted in the US FDA and EU MDR product approvals.
Toxicological Hazard Evaluation, SDS, and Labeling: Managed a large team to provide Globally Harmonized System of Classification and Labelling of Chemicals (GHS) hazard evaluations of thousands of chemicals. Spearheaded the database automation of product-level hazard classifications. Collaborated with external IT firm to expand the client’s existing chemical compliance database by automating TSCA reporting requirements.
Alternatives Assessment for 6PPD: Conducted an alternatives assessment for 6PPD in motor vehicle tires under California’s Safer Consumer Products (SCP) program. Working with a consortium, identified and evaluated potential alternatives to prioritized chemical, aiming to identify safer alternatives. Gradient’s evaluation was submitted and accepted by regulators.
Zhang, J; Tuit, C; Carra, R. 2026. “Crossing State Lines: Practical Strategies for Navigating PFAS Reporting Regulations, Enforcement Actions, and Testing from Consumer Goods to Medical Devices.” Gradient webinar co-presented with Beveridge & Diamond, March 11.
Lewandowski, TA; Zhang, J. 2025. “Lessons Learned in Conducting California’s Safer Consumer Products Alternatives Analysis.” Presented at the PSX Conference, Denver, CO, September 16-18, 18p.
Zhang, J. 2023. “What the Regulations Don’t Tell You About Medical Devices: Differences in Expectations Between US FDA CDRH and EU MDR for E&L and Biocompatibility.” Presented at the Pharma Ed Resources Extractables & Leachables Summit 2023, Philadelphia, PA, April 17, 18p.