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Summary

progressive regulatory senior professional with more than 20 years global experience within FDA/eu, canada, asean, bric regulated industries with strong experience in Medical Devices (active medical equipment/devices, implants (short/long term), radiation therapy, image Diagnostics, monitoring, catheters), companion Diagnostics/IVD (combinations), Pharmaceutical products and international regulatory laws and standards including Compliance. strong experience in class i, ii, iii Medical Device Regulatory Affairs having prepared and submitted numerous submissions, and acting as an agency liason obtaining approvals/clearances. manage premarket and Compliance activities world-wide. - management of ra - direct FDA, notified body, Health canada, japan, brazil, china, russia, korea, mexico etc. experience - experience in pma, 510(k) submissions, experience in Health canada submissions, experience in pmda submissions, experience in anvisa submissions, experience in cfda/kfda submissions etc. - experience in eu conformity process and eu regulations - qa according to FDA qsr, ISO 13485, cmdr, jpal, etc. - mentoring/Training - specialities: Regulatory Affairs, development of global regulatory Strategy, intelligence/monitoring, support to new Product Development projects, submission and filing, Project Management (Regulatory Affairs portfolio), establishment of ww master files, feed back on impact to new/changed legislation to management, Change Management, review of Marketing materials key words: speed-to-market and turn key

Experiences

Current Experience

  • Regulatory Affairs Lead Manager


    Since April 2013

  • Regulatory Affairs Manager


    Since August 2010

Past Experience

  • Regulatory Affairs Manager

    January 2008 --- September 2010

  • Regulatory Affairs Specialist

    January 2007 --- October 2008

  • Regulatory Project Manager

    June 2005 --- January 2007
    top2a fish pharmdx - regulatory Project Manager for FDA class iii pma application as companion Diagnostic (combination product). application area within breast Cancer Diagnostic.

  • Regulatory Affairs Specialist

    February 2002 --- January 2007

  • Regulatory Affairs Project Manager

    December 2003 --- May 2005
    her2 fish pharmdx kit - regulatory Project Manager for FDA class iii pma application as companion Diagnostic (combination product). application area within breast Cancer Diagnostic.

  • Senior Regulatory Affairs Associate

    January 1990 --- January 2002

Knowledge

LinkedIn Assessment :
Regulatory affairsMedical DevicesFDAQuality SystemsCompliance510 KQuality Assurance (QA)AuditingISOISO 13485Regulatory submissionsCAPAUltrasoundDesign ControlISO 14971CE markingDiagnosticsStentsInterventional RadiologyPMAImplantsPharmacogenomicsRegulatory StrategyJapanChinaBrazilCanadaProject PlanningRegulatory RequirementsPharmaceuticalsInternal AuditPharmacovigilanceClinical trialsPost Market SurveillanceRegulatory IntelligenceTechnical FilesValidationeCTDGMPV&VFDA GMPStrategyQuality Systems21 CFRCombination ProductsIVDRegulations

Education

  • in from Kastrupgaardskolen in 0000

Area / Region

Denmark

Others

Driving License
  • No

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