Experience

Mittal Consulting LLC

• Medical Equipment Manufacturing

• Founder and CEO

  • Aug 2020 - Present

  Portland, Oregon Metropolitan Area



Institute of Translational Health Sciences

• United States
• Research Services
• 1 - 100 Employee

• Advisor, Drug and Device Advisory Committee

  • May 2023 - Present

  Seattle, Washington, United States



LivaNova

• United Kingdom
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Regulatory Affairs Consultant

  • Oct 2021 - Present

  Houston, Texas, United States



Johnson & Johnson

• Law Practice
• 1 - 100 Employee

• Regulatory Affairs Consultant

  • Aug 2020 - May 2023

  Irvine, California, United States Regulatory Affairs Consultant for Johnson and Johnson Surgical Vision (JJSV) branch. Completed submissions to both the FDA, Health Canada and EU for all intra-ocular lens (IOL) products including all TECNIS lines.



BIOTRONIK

• Germany
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Regulatory Affairs Specialist

  • Feb 2020 - Aug 2020

• Regulatory Affairs Specialist II

  • Apr 2018 - Feb 2020

• Regulatory Affairs Specialist

  • Jan 2017 - Apr 2018

  • Peripheral Vascular Intervention Product Lead. Additionally lead for UDI and FDA Device Listing. • Coordinated, authored and prepared product submissions to the FDA which include: PMAs, PMA Supplements / Amendments, IDEs and 510(k)s/Special 510(k)s to ensure timely approval. • Prepared reports required for products and devices that have been approved by investigational device exemption (IDE) and pre-market approval (PMA) process. • Researched competitive product approval status and… Show more • Peripheral Vascular Intervention Product Lead. Additionally lead for UDI and FDA Device Listing. • Coordinated, authored and prepared product submissions to the FDA which include: PMAs, PMA Supplements / Amendments, IDEs and 510(k)s/Special 510(k)s to ensure timely approval. • Prepared reports required for products and devices that have been approved by investigational device exemption (IDE) and pre-market approval (PMA) process. • Researched competitive product approval status and emerging FDA requirements and guidance to support timely approval of submissions. • Determined design validation and qualifications test requirements for FDA submissions of new products or product changes and provide guidance on these matters to design engineering and validation personnel. • Reviewed design validation and qualification test results and prepared clear and concise summaries for submission to FDA. • Reviewed product marketing and promotional materials to ensure compliance with FDA requirements • Review and prepare software development, verification, and validation documentation and reports for FDA submissions. • Assist with preparation and update of technical manuals and other product labeling as necessary to comply with FDA requirements; review labeling generated for compliance with FDA and BIOTRONIK requirements. • Interface with Regulatory Affairs counterparts and research & development personnel at BIOTRONIK in Germany and Switzerland. • Driving department process improvement in multiple ways which include the automation of tracking and analysis of project status



Stryker Sustainability Solutions

• United States
• Medical Equipment Manufacturing
• 400 - 500 Employee

• Regulatory Compliance Specialist

  • Feb 2016 - Jan 2017

  •Led Stryker’s largest recall to date. Wrote and submitted 806 form to FDA. Managing relationship with third party and in house inventorying and disposition of product. Primary point of contact for management, third party, sales force and customers. •Managed complaints and filed Medical Device Reports (MDRs) for vascular and non-invasive products. •Compiled complaint and sales data for multiple Health Canada submissions. •Performed monthly trending analysis of complaint data and… Show more •Led Stryker’s largest recall to date. Wrote and submitted 806 form to FDA. Managing relationship with third party and in house inventorying and disposition of product. Primary point of contact for management, third party, sales force and customers. •Managed complaints and filed Medical Device Reports (MDRs) for vascular and non-invasive products. •Compiled complaint and sales data for multiple Health Canada submissions. •Performed monthly trending analysis of complaint data and lead presentations to drive product improvement. •Addressed escalated customer issues by analyzing complaint data. •Provided front room support for corporate, FDA and ISO audits. •Executed MAUDE searches and collateral review. Conducted post market surveillance and drove process improvement. Show less

• Global Quality Operations Engineer

  • Jun 2015 - Aug 2015

  I spearheaded a design change to remove a manufacturing step in the reprocessing of electrophysiology catheters. Working with a cross-functional team, I wrote a validation plan, an operational qualification protocol (OQ-P) and a process qualification (PQ) plan. After obtaining signatures for the OQ-P, I led conference calls to setup the design of the experiment. Upon completion of the design change, it is estimated to save the company approximately $230,000 annually.



Healthcare Excellence Institute

• United States
• Medical Practices

• Biomedical Engineer Researcher

  • Jan 2015 - May 2015

  Supported the development of an application called HealthSignal which is used for chronic disease patients to help effectively monitor their condition using feedback from friends, family and health care providers. Primarily focused on creating a chronic disease catalog with all metrics for each disease. Also worked to support all avenues of development including marketing, sales to target audience and website enhancements during the alpha stage.



Noraxon USA

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Aug 2014 - Mar 2015

  My responsibilities focused on both engineering management and policy compliance. I worked with employees from all branches of the company in order to create the most effective and efficient set of Quality System Regulations (QSR) that comply with FDA requirements and regulations. I presented the final set of documents during the European Union CE audit. I also worked on GSA purchasing and other administrative duties.

• Quality Control and Development Engineer

  • May 2014 - Aug 2014

  My responsibilities focus on QSR regulation compliance and quality control for Noraxon medical products. Projects that I have completed include: • Independently renovating the entire Final Inspection process for EMG equipment using lean processes. • Implementing an intuitive final inspection testing station and unifying and standardizing final inspection procedures. • All changes have been implemented at Noraxon and the average shipping time has decreased … Show more My responsibilities focus on QSR regulation compliance and quality control for Noraxon medical products. Projects that I have completed include: • Independently renovating the entire Final Inspection process for EMG equipment using lean processes. • Implementing an intuitive final inspection testing station and unifying and standardizing final inspection procedures. • All changes have been implemented at Noraxon and the average shipping time has decreased from 2 weeks to 4 days.



Arizona State University

• United States
• Higher Education
• 700 & Above Employee

• Neuropathy Laboratory Researcher

  • May 2013 - Jun 2014

  Researched the effects of a saturated fat diet in adolescent rats on pre-metabolic syndrome and type II diabetes. Conducted neuropathy tests, gavaged rats, assisted in performing euthanasias, and conducted data analysis. Preliminary findings were positive resulting in the design of a larger experiment.

• Groundwater Remediation Laboratory Researcher

  • May 2012 - Aug 2012

  Re-engineered an early remediation device that detected concentrations of various insecticides in ground water. Deployed device several times in West Phoenix and analyzed data collected using mass spectrometry. Initial device design became fully functional however more modifications were needed to expedite the process.



Donald Danforth Plant Science Center

• United States
• Biotechnology Research
• 300 - 400 Employee

• Biofuel Laboratory Researcher

  • May 2011 - Aug 2011

  Characterized human carbonic anhydrase II transformants of Chlamydomonas reinhardtii with potential for increased carbon dioxide availability. Extracted chlorophyll and measured photosynthetic rates with an oxygen electrode, extracted RNA and performed imaging using confocal microscopy to conduct growth curves. Presented at Danforth Symposium (Aug. 5, 2011).

• Cassava Biofortification Laboratory Researcher

  • May 2010 - Aug 2010

  Biofortified cassava tubers for Sub Saharan Africans through genetically increasing zinc and protein levels while reducing cyanide concentration. Extracted DNA, ran PCR and Gel Electrophoresis; micropropagated transgenic cassava by sub-culturization and performed protein analysis on harvested leaves. Findings include both root and leaf protein levels of transgenics showed 2-3 fold increase compared to wild type. Presented at Danforth Symposium (Aug 6, 2010). Listed in Acknowledgement… Show more Biofortified cassava tubers for Sub Saharan Africans through genetically increasing zinc and protein levels while reducing cyanide concentration. Extracted DNA, ran PCR and Gel Electrophoresis; micropropagated transgenic cassava by sub-culturization and performed protein analysis on harvested leaves. Findings include both root and leaf protein levels of transgenics showed 2-3 fold increase compared to wild type. Presented at Danforth Symposium (Aug 6, 2010). Listed in Acknowledgement section for contributing to the research presented in the paper attached below (as Kristen Latta). Show less