Medpoint » Clinical Programs http://www.medpoint.com Device, Pharmaceutical, Biotech Wed, 25 Aug 2010 16:33:01 +0000 http://wordpress.org/?v=2.8 en hourly 1 P.M.N. http://www.medpoint.com/penny/ http://www.medpoint.com/penny/#comments Sat, 25 Oct 2008 15:48:53 +0000 PECULIAR http://medpoint.timpecoraro.com/?p=56 RAC/CQA professional with over twenty-five years experience with Medical Device Regulation in Compliance Management, Regulatory Affairs, Quality Systems and Clinical Affairs. Specializes in creative regulatory strategies to expedite product registrations.

Director of Regulatory Affairs; Corporate Director, RA/QA; Manager of Regulatory Affairs; RA/Clinical Associate

  • Develop Design Control Systems and Implementation; experienced in working with product development teams to get medical devices to market in a timely manner
  • Strong experience with Regulatory Compliance Programs, GMP/QSIT Audits, and Gap Analysis
  • Develop and implement ISO 13485 compliant Quality Systems
  • Possess extensive knowledge and expertise of FDA device regulations, EU Medical Device Directive (MDD), Notified Body Audits, FDA QSIT inspections, and IRB/IDE submissions
  • International Submissions: Design Dossier and Technical File Development; Lead CE mark projects
  • Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees
]]> http://www.medpoint.com/penny/feed/ 0 This is a consultant opening post http://www.medpoint.com/this-is-a-consultant-opening-post/ http://www.medpoint.com/this-is-a-consultant-opening-post/#comments Fri, 24 Oct 2008 17:40:35 +0000 PECULIAR http://medpoint.timpecoraro.com/?p=34 Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Duis dignissim laoreet velit. Morbi metus massa, aliquam ut, elementum vel, malesuada in, urna. Vivamus tempus, ante ut facilisis pretium, purus ligula facilisis quam, vitae vehicula lorem ante ac dolor.

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