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November 8, 2012News for medical technology professionals

  Top Story 
  • LDR closer to FDA approval for cervical disc device
    The FDA has issued an approvable letter to LDR for its Mobi-C system, a metal and polyethylene mobile bearing prosthetic device tailored for use in one- to two-level cervical disc replacement procedures. The company expects to satisfy the remaining approval requirements and release the device in the U.S. next year. (11/7) LinkedInFacebookTwitterEmail this Story
Streamline Combination Product Development
This complimentary white paper from Novella Clinical explores combination product regulatory strategies - from classification to market clearance. Combination product sponsors can avoid numerous regulatory hurdles by downloading this white paper now: Clarifying the Regulatory Road for Combination Products.
  Business & Market Trends 
Online Biotech Grad Programs from Johns Hopkins
Become a leader in biotechnology with a graduate program from Johns Hopkins AAP. We offer 8 flexible online graduate degrees and certificates ranging from Biotech to Regulatory Science. Gain the expertise necessary to excel in and beyond the lab at a world-renowned university. Learn more.
  International Developments 
  Industry Insight 

  Science & Health 
  Emerging Technologies 
  • Mini sinus implant from Intersect gains FDA approval
    The FDA has granted Intersect ENT approval for its Propel mini implant, a second-generation, smaller version of its steroid-eluting device designed to treat patients with chronic sinusitis. The company plans a limited U.S. launch of the device this month and a nationwide release next year. (Boston) (11/6) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
  • Medtech industry seeks lame-duck session repeal of device tax
    Industry stakeholders are bracing for post-election efforts to strike down the 2.3% tax set to be levied against medical devices next year. "[W]e will continue to work to highlight what we think are the negatives of the policy for the industry," said J.C. Scott of the Advanced Medical Technology Association, who noted support from House Democrats and incoming Democratic senators for a repeal of the tax. FierceMedicalDevices (11/7) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • Foreign Corrupt Practices Act (FCPA) Seminar for Medical Devices
    Tuesday, Nov. 13
    AdvaMed headquarters, Washington, D.C.
    Learn the latest trends in FCPA enforcement and lessons learned on third-party compliance management. Participate in a panel discussion with industry experts about FCPA risks in Brazil, China and India, and learn how to navigate other global anti-corruption risks. Network with industry experts, receive guidance and obtain up-to-the-minute information on the FCPA. Register for the seminar. LinkedInFacebookTwitterEmail this Story
  • Follow AdvaMed on Google+
    Stay updated on industry news and educational opportunities -– receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Network with industry experts and leaders. Our Google+ page is interactive and incorporates updates from key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Follow us on Google+. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Director of Quality CEA Medical Manufacturing Colorado Springs, CO
Director, Global Labeling - 001592Edwards LifesciencesIrvine, CA
Director, Valve Testing - Transcatheter Heart Valve - 001221Edwards LifesciencesIrvine, CA
Compliance Manager, Global DistributionCooperVision, Inc.Rochester, NY or Pleasanton, CA, NY
Associate Director, Regulatory AffairsAbbott LaboratoriesSanta Clara, CA
Senior Marketing Communications Manager - Cardiac Surgery Systems - 001558Edwards LifesciencesIrvine, CA
Packaging Engineer/Project LeaderEndologix, Inc.Irvine, CA
Sr. Manager R & D, Systems Integration EngineeringAbbott LaboratoriesSanta Ana, CA
Physician Training Program ManagerEndologix, Inc.Irvine, CA
Director Clinical Research - CapnographyCovidienBoulder, CO
Regulatory Affairs Associate DirectorAbbott LaboratoriesSanta Clara, CA
Field Service Engineer IRIS International, IncSacramento, CA
Quality EngineerIRIS International, IncChatsworth, CA
Medical and Clinical Laboratory TechnologistIRIS International, IncChatsworth, CA
Senior Mechanical EngineerIRIS International, IncChatsworth, CA
Clinical & Customer Care SpecialistIRIS International, IncLos Angeles, CA
Developmental Cell Biologist/BiochemistIRIS International, IncCarlsbad, CA
Principal Systems Engineer IRIS International, IncChatsworth, CA
Field Service Engineer IRIS International, IncProvidence, RI
Director Professional Medical Education CovidienBoulder, CO
Click here to view more job listings.

Leave other people's mistakes where they lie."
--Marcus Aurelius,
Roman emperor

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