Alex Friedman Email and Phone Number
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Strategies for innovative AI-enabled SaMD and electromechanical devices, from concept to market.Authentic regulatory professional who gains the trust and respect of teammates and multi-disciplinary leaders to achieve solid SaMD/AI and electromechanical regulatory strategies and submissions. Experienced in submissions of low to moderate-high risk devices and recognized as an expert in AI-enabled and clinical decision support software. Working knowledge of regulatory requirements for basic safety and essential performance, usability, biocompatibility and reprocessing of medical devices. Passionate about leveraging self- and team-expertise to guide new products through regulatory processes, and proactively share best practices, creative strategies and regulatory knowledge. Balances regulatory and business risks to accelerate best in class solutions to market, and total product life cycle solutions.* Global submissions preparation and additional information responses* AAMI TIR34971, IEC 62304, IEC 60601, IEC 62366, ISO 10993, TIR12* Strategies development and alignment* Business partner regulatory due diligence * Guidance documents interpretation* Regulatory intelligence and research* Design History File review and critical feedback* White papers, dynamic presentations and training* Teaming to find solutions* Technical file maintenance
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Regulatory Affairs Consultant - Medical DevicesSelf-EmployedPittsburgh, Pa, Us
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Staff Regulatory SpecialistBeckman Coulter Diagnostics Aug 2022 - PresentBrea, California, Us
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Senior Regulatory Affairs EngineerPhilips Respironics Mar 2013 - Aug 2022Amsterdam, Noord-Holland, Nl -
Regulatory EngineerPhilips Respironics Aug 2010 - Mar 2013Amsterdam, Noord-Holland, Nl
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Senior Regulatory And Quality EngineerRegulatory And Quality Solutions, Llc Jul 2009 - Aug 2010
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Quality Assurance ManagerCellumen, Inc. Sep 2007 - Jun 2009UsI designed, implemented and managed quality assurance and quality control systems. -
ConsultantFranklin Scientific Consulting Jan 2005 - Sep 2007I managed high tech, biotech and bioengineering projects for organizations on an as-needed basis. The projects have included technology evaluations for business potential, quality management, clinical trial management, program design and launch, organizational communication systems, grant writing and others. As a consultant I also worked with non-profit and university entities to help commercialize technologies.
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Consultant / Project ManagerRenal Solutions 2007 - 2007I organized the interactions between the clinical training staff, logistics, service and regulatory compliance. Communication was improved, problems solved more quickly and team morale raised.
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R&D Scientist / Product Sustaining ManagerCellomics May 1998 - Aug 2004UsAs a scientist I evaluated new technologies to improve the performance of high content screening instrumentation. I also managed a number of small, and one large, product development projects. I am lead author on the third Cellomics patent, and co-author on two other patents. I also developed manufacturing and service trade secrets. As Product Sustaining Manager I tracked and reported on the company's response to Customer Complaints and Product Defects. I also drove the delivery of the solutions to the customers by setting up a tracking system in Customer Relationship Management database, and interacting with the various personnel to identify problems and solve them. -
Postdoctoral FellowStanford University Mar 1995 - Apr 1998Stanford, Ca, UsAs a postdoc I performed research on novel myosin ATPases (proteins). More specifically I expressed and purified mutant myosin molecules that hydrolyzed ATP very slowly. These constructs allowed for one of the first measurements of the ATP off-rate from a myosin molecule because ATP is hydrolized quickly in wild-type myosin. The work was part of an international collaboration.
Alex Friedman Skills
Alex Friedman Education Details
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University Of PennsylvaniaBioengineering -
Binghamton UniversityApplied Physics
Frequently Asked Questions about Alex Friedman
What company does Alex Friedman work for?
Alex Friedman works for Self-Employed
What is Alex Friedman's role at the current company?
Alex Friedman's current role is Regulatory Affairs Consultant - Medical Devices.
What is Alex Friedman's email address?
Alex Friedman's email address is af****@****zon.net
What is Alex Friedman's direct phone number?
Alex Friedman's direct phone number is (800) 555*****
What schools did Alex Friedman attend?
Alex Friedman attended University Of Pennsylvania, Binghamton University.
What are some of Alex Friedman's interests?
Alex Friedman has interest in Leadership, Biotech/bioengineering Start Ups, Guitar, Team Building, Band Leadership, Sports In General, Music, Microscopy/optics, Tennis, Percussion.
What skills is Alex Friedman known for?
Alex Friedman has skills like Medical Devices, Biotechnology, R&d, Product Development, Quality Assurance, Regulatory Affairs, Iso 13485, Fda, Quality Management, Capa, Design Control, Quality System.
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