Arti Arvind

• Lead and manage the regulatory team within the Advanced Wound Bioactives (AWB) business on regulatory strategy and global registrations of Biologics, HCT/Ps and Device-Biologic combination products. • Lead the regulatory team through all FDA submissions including FDA sBLA CMC submissions for SANTYL and REGRANEX, device-led combination product submissions including De Novo, 510(k), PMA's as well as HCT/P 361 FDA TRG submissions. • Manage the advertising and promotional compliance activities for Biologics including FN2253 submissions to FDA. • Provide guidance to the cross-functional teams and senior management on impact of new or changed regulatory requirements and advise on compliance and risk mitigations where needed. • Support AOP and manage the AWB regulatory budget to optimize revenue and expenditure; act as change champion lead for cost-reduction and RA transformation initiatives.

• Adjunct faculty at the NEU College of Professional Studies for the Master of Science program in Regulatory Affairs for Drugs, Medical Devices and Biologics.

• Lead and manage the IVD regulatory team responsible for regulatory strategy and global registrations of in-vitro diagnostic assays such as Hematology and Urine Diagnostic tests. • Lead the regulatory strategy for the next-gen diagnostic tests that used machine learning/AI digital technology to improve clinical outcomes. • Partner with program management and R&D to drive the roadmap for new product developments (NPDs) and IVDR compliance.

• Lead and manage the Obstetrics - Fetal monitoring & Connected Sensing regulatory team by providing leadership on regulatory strategy and global registrations of NPIs, MDR compliance, and sustaining releases. • Previously, Regulatory Program Manager responsible for EU MDR regulatory strategy and deployment resulting in successful delivery of MDR compliant products. Acted as regulatory lead during MDSAP audits and point person for interfacing with Notified Body.

• Provide global regulatory strategy for registration of Philips Image Guided Therapy Systems (IGT-S) headquartered in Best, Netherlands • Act as chair of Standards Roadmap team and project manage assessment of new standards and changes to regulations • Oversee and approve various product development gates and phases for NPI/large scale projects and design changes during Program Management Team meetings. • Strategize and program manage EU MDR deployment for IGT-S Class IIb products

• Provide regulatory support and strategy for NPI and sustaining projects for both standalone imaging software (SaMD) and hardware (capital equipment such as Ultrasound diagnostic systems and transducer, and Patient Monitoring systems and accessories) • Regulatory SME for the Artificial Intelligence regulatory strategy for Ultrasound systems; SME for state of the art standards compliance. • Prepare and submit traditional 510(k)’s to FDA, Health Canada Class II and III submissions, provide China type testing strategy and NMPA product registrations, maintain EU technical files, DoC’s and CERs, support registrations in other major key markets such as Brazil, Singapore, Korea, Japan, Russia and Malaysia. • Provide regulatory support for MDSAP, FDA and Notified Body audits. • Regulatory SME for the EU MDR gap analysis evaluation; provide strategy in addressing gaps in clinical evaluation and other new requirements in the MDR. • LEAN certified and knowledgeable in Lean methodologies and deployment.

• Regulatory lead for global registrations for Optical Coherence Tomography (OCT) Imaging Systems and sterile intravascular imaging catheters. • Submit FDA IDE supplements and IDE annual reports for the Thoratec Percutaneous Heart Pump system (PHP - LVAD device). • Prepare and submit Health Canada Class III submissions, EU MDD Design Dossier supplements to Notified Body for EU Class III imaging catheter changes.

• Provided regulatory support and representation for in-vitro diagnostic (IVD) new product development and design change projects. • Prepared pre-IDE and 510(k) submissions to FDA, prepared strategy and meeting materials for Pre-Submission meetings as well as Submission Issue meetings, and represented Regulatory Affairs during in-person meetings with FDA. • Interfaced with a key team of OEM manufacturers located OUS to strategize submission requirements to FDA including acceptable performance criteria in comparison to the predicate, as well as requirements for EU and US clinical trials. • Prepared submissions for European regulatory approvals (CE mark applications, EU Technical Files, DOCs etc.), global dossiers and supported Health Canada submissions. • Regulatory SME for the core team involved in complying with the FDA UDI final rule. • Prepared annual laser reports and Certificate to Foreign Government applications to FDA, and maintained establishment registration and device listing for all products.

• Developed a conceptual and dynamic mathematical model to quantify the recontamination risk in ice cream products. Conducted statistical analysis and suggested risk management options to reduce the identified risk. • Tested and identified possible biological indicator groups of microorganisms that might occur with Listeria species in sampled biofilms. • Conducted environmental monitoring procedures at Unilever ice cream factories and tested product conformance to manufacturing standards. • Conducted an in-depth literature review of various recontamination scenarios that might occur during the manufacture of ice cream products. Generated input parameters for the mathematical model and validated the same.

• Using bio-analytical techniques, identified biomarkers that could serve as predictive cellular indicators for the stress adaptive behavior of the pathogen Bacillus cereus. • Performed benchwork using traditional techniques such as microbial culturing, plating and streaking as well as molecular biological techniques (RT-PCR and SDS PAGE). • Co-authored a paper on the research work which has been published in Plos One journal entitled, “Short- and Long-Term Biomarkers for Bacterial Robustness: A Framework for Quantifying Correlations between Cellular Indicators and Adaptive Behavior” (October, 2010).

Recipient of the Regulatory Affairs scholarship award Courses: Drug and device regulations, Human experimentation, Regulatory overview of New Drug development, Regulatory overview of Medical device development, Regulatory overview of Biologics development, Clinical trial design and data analysis, Advanced writing in International biomedical topics, Canadian and Australian medical device regulations, International regulations - Canadian, Asian and Latin American Regulatory Affairs, Advertising and Promotion of drugs and devices, FDA law.

Graduated with the highest distinction from the MSc study. Won the Wageningen University Fund (WUF-KLV) Best Dissertation Award for the MSc study