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Ian Feldberg is listed as Medical Device Executive and Entrepreneur at Rejoni, Inc, based in Sudbury, Massachusetts, United States. AeroLeads shows a work email signal at earthlink.net and a matched LinkedIn profile for Ian Feldberg.
Ian Feldberg previously worked as Vice President Clinical Research and Regulatory Affairs at Rejoni, Inc and Principal at Ibf Consulting Services. Ian Feldberg holds Physics Postgraduate Phd Studies, Microwave Surgical Devices from University Of Bath.
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Medical Devices Consulting Services, Interim VP➢ Strategy, Business Development, R&D, Clinical Trials, Global Regulatory Affairs➢ Trained in Electronics Engineering and Biomedical Physics Postgraduate Research➢ 25+ years medical device experience (Engineer, Manager, Director, VP, CTO)➢ Versatile skill-set (Management of large teams: R&D, Regulatory Affairs, Manufacturing)➢ Track record of distilling complicated science to bring novel technologies to market quickly➢ Tenacious problem solver possessing an ability to find elegant and least burdensome solutionsI am an accomplished technical leader; having conceptualized product pipelines and represented several medical device companies in their relationships with customers, distributors, professional societies, suppliers, competitors, government agencies and regulators. I have successfully provided management leadership to cross-functional teams, accepting responsibility, driving action and building relationships of trust with team members.I have a deep knowledge of FDA medical device regulations, guidance and export requirements as well as European, Canadian, Australian, Chinese and Japanese approval processes. I have worked directly with international regulatory agencies to negotiate novel pathways and navigate original applications and amendments/supplements to a successful outcome.Specialties: Research and Development of minimally invasive surgical products, tissue ablation, welding and cutting. Design, execution and analysis of preclinical and clinical studies. Technology assessment, Product pipeline planning. US and EU approvals, CE Mark, PMA, 510(k) submissions, responses, panel meetings, vigilance reporting and product labeling.
Listed skills include Medical Devices, Fda, R&D, Product Development, and 46 others.
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Bedford, Massachusetts, Us
Rejoni is committed to using its expertise in biomaterials to develop products that improve the outcomes of minimally invasive and other gynecological surgical procedures.
Medical Devices Consulting Services - Interim VP➢ Cardiovascular: Implant design (measurement of pulmonary pressure); Electronic home-use system; Home-link database; Catheter Design; R&D planning; Authoring SOPs; Managing CAPAs; Supporting FDA audits; Managing V&V and Software Validation; FMEA; Compiling and Submitting PMA and Technical File, DHF’s, CE Mark; Authoring manuals and product labeling➢ Oncology: Multiple RF and Microwave tumor ablation systems; Robotic assisted tumor ablation treatment planning system; Design optimization, Ablation data generation, 510(k) submissions➢ Women’s Health: Endometrial Ablation, Fibroids and Tubal Occlusion Expert; Post-market clinical validation studies; PMA Supplements; Technology assessment (RF, microwave, ultrasound and vaporous energy for Fibroids); Design optimization; Dual Energy Therapy Needle US 2010/0286687
Technology transfer of a highly accurate SAW wireless PAP sensor implant and wearable electronics to monitor hemodynamics for HF patient use at rest or during activity.
Microsulis successfully introduced medical device products in the global Women’s Health and Oncology market sectors. The product lines were sold to Hologic in February 2011 and AngioDynamics in March 2012.➢ Managed large R&D groups; Developed programs to encourage personal and professional growth➢ Provided engineering oversight of technology transfer and new manufacturing processes➢ Chaired Medical Advisory Board and Medical User Group Forums with Key Opinion Leaders➢ Raised significant funds and built a global company that manufactured Class II and Class III devices➢ Led successful submissions securing PMAs, PMA supplements, 510(k), CE Mark Accreditations➢ Initialed first human use clinical trials, randomized controlled trials, and global post marketing studies➢ Maintained quality, accuracy and business strategy in technical writing for regulatory submissions➢ Medical device inventor for multiple clinical markets; R&D leader; Regulatory Affairs troubleshooter➢ Accomplished speaker: Conferences, Exhibitions, FDA Medical Advisory Panels, Sales meetings
Romsey, England, Gb
*** Microwave Physics, Medical device R&D, Clinical Research ***As part of a diversification initiative, defense company Chemring Group funded Ian Feldberg’s PhD research.Responsibilities: All prototyping, empirical bench testing, pre-clinical and clinical trials.Achievements: Invented novel dielectric filled waveguide antenna for medical use. Developed prototype medical devices and managed clinical trials of the devices on consenting patients at the Royal United Hospital in Bath. Produced strategic business plans for funding medical device start-up and named the company Microsulis (Micro for Microwave and small. Sulis for Sulis-Minerva, goddess of the hot spring at Bath, which was known throughout history for it’s healing powers).
*** IC design and fabrication, CMOS gate architecture, Physical Modeling ***Designer and manufacture of innovative CMOS image sensor technology.Responsibilities and Achievements: Specialized in device physics and qualification of new CMOS memory processes. Became the company expert on simulation of CMOS circuit degradation due to Hot-Carrier effects.
*** ASIC and Discrete Electronic Circuit Design, LCD Production Systems ***Communications start-up with mobile Teletext technology.Responsibilities and Achievements: Design of analogue and digital circuits, ASICs. Design of RF circuits and production test equipment for a high-resolution miniature LCD. Produced custom LCD manufacturing techniques that increased yield by 45%.
*** Interface and Instrumentation Software, Custom Automatic Test Equipment ***One of the first specialized industrial research laboratories to be built in the UK. Ian Feldberg received a scholarship for industrial research in the area of instrumentation.Responsibilities and Achievements: Design of discrete hardware and software driver routines for prototype automatic test equipment. Completed project work on time.
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Ian Feldberg works for Rejoni, Inc.
Ian Feldberg is listed as Medical Device Executive and Entrepreneur at Rejoni, Inc.
AeroLeads has found 1 work email signal at @earthlink.net for Ian Feldberg at Rejoni, Inc.
Ian Feldberg is based in Sudbury, Massachusetts, United States while working with Rejoni, Inc.
Ian Feldberg has worked for Rejoni, Inc, Ibf Consulting Services, Cardian, Microsulis, and Chemring Group Plc.
You can use AeroLeads to view verified contact signals for Ian Feldberg at Rejoni, Inc, including work email, phone, and LinkedIn data when available.
Ian Feldberg holds Physics Postgraduate Phd Studies, Microwave Surgical Devices from University Of Bath.
Ian Feldberg is listed with skills including Medical Devices, Fda, R&D, Product Development, Commercialization, Regulatory Affairs, Cross Functional Team Leadership, and Biomedical Engineering.
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