Regulatory affairs engineer
Tata Elxsi limited
مجموع سنوات الخبرة :3 years, 3 أشهر
Conducted comprehensive data collection from various material suppliers to ascertain their usage of PFAS (Per/Poly fluroalkyl substances) and procurement sources like 3M, PPG, etc., through customized survey forms for each supplier.Spearheaded the identification of alternative suppliers for PFAS materials, ensuring compliance with EU legislation during the derogation period, and supporting the client's sustainability goals.Prepared risk-benefit assessments for devices containing PFAS materials, securing derogation periods from EU regulations and paving the way for sustainable solutions through the exploration of alternative materials.Successfully managed data collection activities to identify PFAS usage in materials, sourcing from suppliers like 3M and PPG.
• Conducted biocompatibility standard gap assessments on medical devices to ensure compliance with global regulatory requirements and standards.
• Effectively contributed in writing biological evaluation reports (BER) for summarizing the biological safety of the medical devices and sent for regulatory submissions.
• Coordinated with test labs and device manufacturers to conduct biocompatibility and chemical characterization testing in accordance with the ISO and other applicable standards.
• Reviewed the study protocol and reports of the biocompatibility studies conducted in the test laboratory by comparing them with the recent guidelines or standards followed in the applicable testing and shared the final protocol and reports with the manufacturer.
• Conducted toxicological risk assessment for the leachables identified in the extractables study by calculating the margin of safety (MoS) of the potential leachable by dividing the obtained tolerable exposure (TE) of the potential leachable and the clinical exposure of the potential leachable
• Prepared 200+ toxicological data for the chemicals present in the medical devices by collecting toxicological endpoints from the literature sources such as ECHA, PubChem, etc.,
• Contributed in creating a toxicological automation tool for the effective calculation of MoS (Margin of safety) and this automation tool includes toxicology data, regulatory limits (Reference dose (RfD), Derived no effect level (DNEL), Acceptable daily intake (ADI), Permissible daily exposure), Toxicokinetics, Pharmacology, and Physiochemical data.
• Conducted CMR assessments on the raw materials present in the medical devices to confirm the presence of CMR 1A or 1B, Endocrine disruptors, etc., are below the threshold limit of 0.1% w/w as per the 2017/745 annex 1, GSPR 10.4 and 10.6 guideline.
• Worked collaboratively with cross-functional teams to resolve biocompatibility issues and provide technical expertise to support product development.
Facilitated risk management activities in alignment with ISO 14971:2019, contributing to project success.Assisted in research and development projects related to infusion pump technology.Conducted quality inspections for infusion pumps and contributed to understanding ISO and regulatory requirements.
Completed my graduation in biomedical engineering by securing a first class in academics and submitted a industrial project in my final year.