Karen J. Email and Phone Number
Dynamic leader with over 25 years experience in managing technology projects and products with profit-loss responsibility. Currently developing regulatory strategy and planning pre-clinical and clinical testing in support of innovative biopharmaceutical combination products and medical device introduction with detailed understanding of the clinical trial market and global regulatory approval process for both Class 2,3, 2b and active implantables. -Designated Management Representative for Quality Management System. Successful ISO13485, FDA and Notified Body Audits-Responsible for the Global Submission of novel orthopedic products.-Responsible for submission and approval of a PMA for an Intragastric Balloon in 2016 and global launch of the product.-Worked with Tier 1 Bio pharmaceutical companies to implement their drug safety systems. -Worked with the FDA on pre-submissions as well as submissions -Implementation of Quality Systems against 21 CFR 820.30, EU MDR, ISO 13485 and MDSAP. -Obtained PMA, 510K, IDE approvals/ clearances, worked with IRBs for clinical trial approval and implementation of EDC/CTMS systems.Spoken at various industry conferences and have two patents in area of signal detection and lead the development of a signal detection management system compliant with CIOMS VIII guidance deployed by 3 Tier 1 Pharmaceutical companies.RAC certification, CITI ICH GCP and Human Research certification, and conducted a multi-center, multi-country clinical trial for a class III active implantable device, pivotal study for OSA (device) and first US study in metabolic imaging for breast cancer.Developed a system for the management of global licenses for large multinational medical device company with the ability to view and manage the process for new product introduction and license renewals.Several patents, publications: November 2010 issue of Pharmacovigilance Review, poster exhibit at DIA Europe 2011, session chair at the DIA 2012, 2013 & 2014 Annual meeting, Apr 2014 in RAPS Magazine.
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Vice President Regulatory Affairs And Clinical DevelopmentSpinal Elements, IncUnited States
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Regulatory, Clinical ConsultantMedical Product Devevelopment Aug 2013 - PresentDevelopment of implanted insulin pump with biosimilar insulin, orthopedic implant for Diabetic Foot Ulcer and small molecule development for rare disease-Development of FDA interactions including BIA, Qsub, 510k and PMA submissions -Protocol development for phase 1 study in Europe -Protocol development for First in Human in Australia
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Vp Ra/Clinical OperationsMannkind Corporation Nov 2020 - PresentDanbury, Ct, UsStrong Leader in Regulatory Affairs strategy and operations and Clinical Operations. Responsible for maintenance of inhaled insulin combination product submissions (PAS, DSUR, IND, Annual Reports) and quality organization, promotional review and compliance and Clinical operations for registrational pediatric study. Responsibilities include module 3 for partnered therapeutic and NDA submission and approval support; Device submission for device constituent component, UDI management and ISO 13485 (lead auditor certified). Responsible for regulatory and clinical operations for new asset under 505(b)(2) combination product for orphan lung disease.Significant experience in device quality systems and submissions for Class II and Class III devices in US and under MDR. -
Clinical Operations And Regulatory Affairs ManagementConsultant Jan 2012 - Aug 2021- Extensive Experience in writing / submission of IDE, 510K, PMA; Obtained clearances and supported FDA meetings including Digital Health Application (SaMD) for Atrial Fibrillation and thermally responsive material for treatment of dry eye and various combination products- Execution of multinational clinical trial for active implantable device responsible for regulatory and ethics approvals, protocol and CRF development, DSMB, CRO management, surgical training, site management and patient recruitment. - US Clinical study for OSA device and metabolic imaging-Developed systems for the management of their global licenses worldwide with the ability to view and manage the process for new product introduction and license renewals based on BI platform and sharepoint based web front end.- Regulatory strategy development for new product introduction; RAC Certified- CE Technical file and Design Dossier development and submission, DeNovo submission, EDC /CTMS knowledge. E-Management systems development for license tracking.- Free lance Notified Body Auditor
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Vp Ra/Qa/CaKeystone Heart, A Venus Medtech Company May 2019 - Jan 2021Responsible for Global Regulatory Submissions, Quality Assurance and Clinical Operations at multinational company focused on Structural Heart Solutions;Combination product / CE marking
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Senior Director, Regulatory, Quality And Clinical AffairsNuvasive May 2017 - Mar 2019San Diego, Ca, Us• Part of Senior Leadership team developing strategic goals for the Orthopedic Business• Responsible for submission and clearance of 510k products, clinical programs and Regulatory Strategy and interacting with FDA and global regulatory authorities • Responsible for incoming Quality Inspections, ISO13485 and Post Market Quality processes (MDR, Vigilance, Field Actions)• Responsible for establishing a reimbursement program and coding guide• Responsible for global registration of company products (US Asia, Middle East, South America, EU)• Work with R&D, Operations and customer service• Developed Custom Device Program• Conducted studies that resulted in peer reviewed publications• Managed the Quality team and Quality Management System; designated Quality management representative -
Director, Regulatory AffairsObalon Therapeutics Oct 2015 - May 2017Carlsbad, Ca, Us-Responsible for PMA Submission and Approval- Interaction with FDA- Coordination with R&D, QA and Clinical -
Regulatory ResearchAlfred Mann Institute 2011 - 2013The Alfred E. Mann Institute for Biomedical Engineering was established at the University of Southern California in 1998 to bridge the gap between biomedical invention and the creation of commercially successful medical products that improve and save lives.Current responsibilities include regulatory strategy and pre-clinical testing design.
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Director, Product StrategyOracle Aug 2009 - Feb 2011Austin, Texas, UsResponsible for strategic product direction for the Business Intelligence, Analytics and Signal Detection. Thought leader within the Pharmacovigilance industry. Lead the strategic development partnerships with Novartis, Quintiles, Merck and Millenium toward industry leading solutions for Signal Management and Business Intelligence. -
Director Product StrategyRelsys - Oracle 2008 - Feb 2011
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Vp Product ManagementRelsys, Inc. Sep 2008 - Aug 2009Relsys was acquired by Oracle health Sciences Global Business Unit!!!
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Vp Product ManagementSendio Jun 2006 - Jul 2008Newport Beach, California, Us -
CtoEagency Systems Feb 2004 - Jun 2006CTO responsible for the creation, deployment and operation of ASP and mobility solution for CRM / SFA solutions. Managed internal and offshore development teams, data center operations, marketing initiatives, vendor relationships and customer management. Product chosen as a winner in the OC High Tech Awards 2006 from the American Electronics Association for Innovative Product - Web services.
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District Sales ManagerData Return, Inc May 2000 - Feb 2004and Arizona responsible for territory development, revenue generation, local partnerships and marketing. Surpassed quota requirements. * Western Region Application Engineering Manager responsible for pre-sales technical support. Focus on Microsoft Technologies Platforms.
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Western Region Sales ManagerVisual Networks, Inc Jan 1997 - May 2000responsible for end-user sales and demand creation from Colorado and west. Created market, exceeded quota, built sales team. * Systems engineer responsible for carrier based implementations of WAN management. Focus on operations deployment, product definition and field engineer training. Lead engineer for design architecture of the AT&T product offering based on Visual Networks systems. Other duties included support for end user implementations.
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Technical Training Product ManagerAt&T Data Communications Services Feb 1996 - Jan 1997for domestic and global high-speed data services. Responsible for customer education and training on data performance for WAN technology. Developed and delivered training materials and course curricula for multi-protocol WAN environments.
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Operations ManagerAt&T Data Communications Services Jan 1995 - Feb 1996for domestic and global high-speed data services. Responsibilities included:Customer network management for large corporate networksNew service introductionGlobal operations expansion.Network upgrade managementProcess development
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Systems EngineerAt&T Bell Laboratories Sep 1989 - Jan 1995Murray Hill, Nj, Usfor international network implementation. Expertise in Frame Relay Service, LAN, WAN, ATM and Digital Circuit Compression technology. Responsibilities included:Customer network technical sales and marketing, and contract negotiationsDesign and implementation of large customer networks, international gateway applications and the domestic AT&T frame relay networkOperational issues for network implementation and maintenanceIntegration of equipment into PTT networksMajor Contracts completed -
Systems EngineerAt&T Information Systems Jul 1986 - Sep 1989for testing Digital PBX Switches, Systems 75 and 85. Responsibilities included:Integration and testing of Digital PBX with other AT&T customer premises, equipment and products from other vendorsSystem documentationMajor Contracts completed: WANG, Local Data, Picture Tel, Internal verification tests.
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InternIbm, Federal Systems Division Jan 1985 - Sep 1985Cooperative Studies program with Georgia Institute of Technology for Computer Engineers. Developed IBM Series/1 programs for control of a hardware simulator. Responsibilities included:Testing and integration of programs with simulator and other hardware.
Karen J. Education Details
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University Of Southern CaliforniaMedical Regulatory Sciences -
University Of Southern CaliforniaMedical Regulatory Sciences
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Nyu Stern School Of BusinessFinance
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Cornell UniversityElectrical Engineering
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Georgia Institute Of TechnologyComputer Science And Ee
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New York University School Of Law
Frequently Asked Questions about Karen J.
What company does Karen J. work for?
Karen J. works for Spinal Elements, Inc
What is Karen J.'s role at the current company?
Karen J.'s current role is Vice President Regulatory Affairs and Clinical Development.
What schools did Karen J. attend?
Karen J. attended University Of Southern California, University Of Southern California, Nyu Stern School Of Business, Cornell University, Georgia Institute Of Technology, New York University School Of Law.
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