Medpoint » Product Releases http://www.medpoint.com Device, Pharmaceutical, Biotech Tue, 31 Jan 2012 21:44:28 +0000 en hourly 1 http://wordpress.org/?v=3.1 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
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