Experience

Infraredx, a Nipro Company

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

• Senior Manager Regulatory Affairs

  • Mar 2023 - Present

  Bedford, Massachusetts, United States



Edwards Lifesciences

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

• Manager

  • Apr 2022 - Mar 2023

  Irvine, California, United States

• Associate Manager

  • Aug 2019 - Apr 2022

  Irvine, CA



KARL STORZ Endoscopy-America, Inc.

• Medical Device
• 700 & Above Employee

• Senior Regulatory Affairs Specialist

  • Jul 2015 - Aug 2019

  El Segundo, California • Prepare and project-manage traditional 510(k) submissions for various electro-mechanical, software-driven, and/or endoscopy Class II devices, including but not limited to: o K161112 KARL STORZ Flexible Video-Neuro-Endoscope System o K161554 ENDOFLATOR 40, ENDOFLATOR 50 o K170462 KARL STORZ ShuntScope o K183264 Flex-THOR Scope o K182186 CMOS Video-Rhino-Laryngoscope System o K182723 Flexible HD-Cysto-Urethroscope System • Prepare and project-manage Supplements… Show more • Prepare and project-manage traditional 510(k) submissions for various electro-mechanical, software-driven, and/or endoscopy Class II devices, including but not limited to: o K161112 KARL STORZ Flexible Video-Neuro-Endoscope System o K161554 ENDOFLATOR 40, ENDOFLATOR 50 o K170462 KARL STORZ ShuntScope o K183264 Flex-THOR Scope o K182186 CMOS Video-Rhino-Laryngoscope System o K182723 Flexible HD-Cysto-Urethroscope System • Prepare and project-manage Supplements, Pre-Submission, Breakthrough Designation Request, IDE, and Annual Reports for Class III and HDE devices: o P050027 KARL STORZ D-Light C PDD System o Class III device (Breakthrough/EAP Designation Granted): IDE in preparation o H040005 Fetoscopy Instrument Set • Lead clinical study activities: Writing protocols & IRB applications, CRO management, and developing SOPs. • Perform gap analysis for existing design validation documents against requirements of various FDA Guidance documents, ISO standards, and predicate devices’ information (i.e., competitor’s 510(k) summaries, IFUs, etc.). • Develop and/or revise test protocols and reports with engineers. • Support technical review and evaluate the US regulatory impact of Engineering Change Orders (ECOs). • Maintain and organize Letter to Files (LTFs) to demonstrate compliance with applicable regulations. • Led UDI project by reviewing and assigning required product information for Class III, II, and I products. Show less



Cook Medical

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

• Regulatory Affairs Specialist (Japanese) & Development Engineer

  • Nov 2012 - Jul 2015

  Bloomington, Indiana Area As a Development Engineer, • Lead the design and development for Peripheral Intervention products (catheters and stents), focused on addressing business and market needs for Strategic Business Unit. • Assisted CAPA projects. • Created clinically simulated bench tests. • Interfaced with Marketing, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors and physicians. • Managed multiple project time lines, resources and responsibilities to… Show more As a Development Engineer, • Lead the design and development for Peripheral Intervention products (catheters and stents), focused on addressing business and market needs for Strategic Business Unit. • Assisted CAPA projects. • Created clinically simulated bench tests. • Interfaced with Marketing, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors and physicians. • Managed multiple project time lines, resources and responsibilities to achieve team, departmental and Business Unit goals. • Followed Design Control procedures and comply with requirements of 21CFR Quality System Regulations, ISO 13485 and ISO 14971. As a Regulatory Affairs Specialist II (Japanese), • Served as a liaison on regulatory issues between the Cook Incorporated and Cook Japan. • Communicated Japan-specific regulatory requirements to the US Regulatory Specialist/Regulatory Science team leaders and assisted with the regulatory submission strategies. • Planned and prepared Japanese regulatory submissions (Shonin, Ninsho, and Todokede) for new products, product changes, and re-registrations. • Maintained registration information. • Performed translation activities for test reports, design validation documents, etc. • Prepared and cleared US Special 510(k) submissions for implantable Class II products: o K150931 MReye Embolization Coils o K150964 MReye Flipper Detachable Embolization Coil and Delivery System • Performed gap analysis for Japan and US against requirements of various ISO standards (ISO 10993, ISO 11070, ISO 25539, etc), JIS (Japan Industrial Standards), Shonin standards, FDA Guidance, competitor’s disclosed information. • Collaborated with Regulatory Scientific Affairs, Engineering, and Business Units. • Provided support to currently marketed products as necessary including input on change requests, etc. • Maintained and organized appropriate regulatory records to demonstrate compliance with applicable regulations. Show less



North County Clinical Research

• Mental Health Care
• 1 - 100 Employee

• Clinical Site Director

  • Aug 2011 - Nov 2012

  Oceanside, CA • Overseeing clinical research operation strategies and five clinical research coordinators and assistants. • Coordinate pharmaceutical sponsored Phase II-IV clinical trials mainly in psychiatry including 2 Major Depressive Disorder trials, 1 Smoking Cessation trial, 1 Opioid Addiction trial, 3 Bipolar Disorder trials, and 3 Schizophrenia trials. • Plan and execute marketing plans. • Utilize knowledge and understanding of Code of Federal Regulations (CFR) and International Conference… Show more • Overseeing clinical research operation strategies and five clinical research coordinators and assistants. • Coordinate pharmaceutical sponsored Phase II-IV clinical trials mainly in psychiatry including 2 Major Depressive Disorder trials, 1 Smoking Cessation trial, 1 Opioid Addiction trial, 3 Bipolar Disorder trials, and 3 Schizophrenia trials. • Plan and execute marketing plans. • Utilize knowledge and understanding of Code of Federal Regulations (CFR) and International Conference on Harmonization (ICH) Guideline to maintain communication with Institutional Review Boards (IRB) regarding study status reports, serious adverse events. • Liaison between research administration, physicians, nurses and other health professionals to optimize patient care and visit efficiency. • Perform medical history interviews, medication reviews, and vital signs on subjects. Show less



Coordinated Clinical Research

• Manager of Recruitment / Clincial Research Coordinator

  • Jul 2009 - Aug 2011

  La Jolla, CA • Coordinate pharmaceutical sponsored Phase I-III clinical trials in neurology including 3 Alzheimer’s Disease trials, 4 Diabetic Neuropathy trials, 2 Amyotrophic Lateral Sclerosis trials. • Build recruitment strategies, identify and screen potential subjects. • Design and maintenance of the company website. • Marketing business to potential sponsors. • Utilize knowledge and understanding of Code of Federal Regulations (CFR) and International Conference on Harmonization (ICH)… Show more • Coordinate pharmaceutical sponsored Phase I-III clinical trials in neurology including 3 Alzheimer’s Disease trials, 4 Diabetic Neuropathy trials, 2 Amyotrophic Lateral Sclerosis trials. • Build recruitment strategies, identify and screen potential subjects. • Design and maintenance of the company website. • Marketing business to potential sponsors. • Utilize knowledge and understanding of Code of Federal Regulations (CFR) and International Conference on Harmonization (ICH) Guideline to maintain communication with Institutional Review Boards (IRB) regarding study status reports, serious adverse events, safety reports, protocol amendments, and Informed Consent Form (ICF) modifications. • Liaison between research administration, physicians, nurses and other health professionals to optimize patient care and visit efficiency. • Perform medical history interviews, medication reviews, and vital signs on subjects. Show less



CHOC Children's

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Coordinator

  • May 2008 - Jul 2009

  Orange County, California Area • Coordinate pharmaceutical sponsored Phase II-IV pediatric clinical trials mainly in pediatric pulmonology including 13 Cystic Fibrosis trials, 7 metabolic disorder trials, 2 gastroenterology trials. • Identify potential participants unique to the trial and recruit them. • Utilize knowledge and understanding of Code of Federal Regulations (CFR) and International Conference on Harmonization (ICH) Guideline to maintain communication with in-house Institutional Review Boards (IRB) regarding… Show more • Coordinate pharmaceutical sponsored Phase II-IV pediatric clinical trials mainly in pediatric pulmonology including 13 Cystic Fibrosis trials, 7 metabolic disorder trials, 2 gastroenterology trials. • Identify potential participants unique to the trial and recruit them. • Utilize knowledge and understanding of Code of Federal Regulations (CFR) and International Conference on Harmonization (ICH) Guideline to maintain communication with in-house Institutional Review Boards (IRB) regarding study status reports, serious adverse events, safety reports, protocol amendments, and Informed Consent Form (ICF) modifications. • Write Informed Consent Form (ICFs) and assents. • Build a study budget. • Liaison between research administration, physicians, nurses and other health professionals to optimize patient care and visit efficiency. • Perform medical history interviews, medication reviews, PFTs (pulmonary function tests), and vital signs on subjects. Show less



Neuropsychiatric Research Center of Orange County

• Clinical Research Coordinator

  • May 2007 - Jun 2008

  Orange County, California Area • Coordinate pharmaceutical sponsored Phase II-IV clinical trials in psychiatry including 1 pediatric Autism trial, 3 Major Depressive Disorder trials, 8 Schizophrenia trials, and 1 Bipolar trial. • Utilize knowledge and understanding of Code of Federal Regulations (CFR) and International Conference on Harmonization (ICH) Guideline to maintain communication with Institutional Review Boards (IRB) regarding study status reports, serious adverse events, safety reports, protocol amendments, and… Show more • Coordinate pharmaceutical sponsored Phase II-IV clinical trials in psychiatry including 1 pediatric Autism trial, 3 Major Depressive Disorder trials, 8 Schizophrenia trials, and 1 Bipolar trial. • Utilize knowledge and understanding of Code of Federal Regulations (CFR) and International Conference on Harmonization (ICH) Guideline to maintain communication with Institutional Review Boards (IRB) regarding study status reports, serious adverse events, safety reports, protocol amendments, and Informed Consent Form (ICF) modifications. • Liaison between physicians, nurses and other mental health professionals to optimize patient care and visit efficiency • Perform medical history interviews, medication reviews vital signs, phlebotomy workups, and ECGs on subjects participating in pharmaceutical sponsored clinical trials. Show less