Anja Kontio

Experience

• 

  Orion Diagnostica

  May 1989 - Jul 2017

  I worked as a Regulatory Affairs Manager. My responsibilities included the follow up and implementation of the European, USFDA and Canadian IVD regulations as well as registration of immunological IVD products globally (EU (other than Annex II), USA 510(k), Canada, Asian countries). I am a lead auditor and I was responsible for conducting internal quality system audits. Registration and sales licenses for IVD products Registration and sales licences for IVD products Quality assurance of IVD products

  • Regulatory Affairs Manager

    Jan 2013 - Jul 2017

  • Registration Manager

    Aug 2008 - Jan 2013

  • Registration specialist

    Jan 2006 - Jul 2008

  • Laboratory Manager

    May 1989 - Dec 2005
• 

  Mectalent Medical Services Oy

  Aug 2017 - Nov 2020

  Manager of Regulatory Affairs

  Regulatory strategies for medical device and in vitro diagnostic medical device manufacturers. 510(k) submissions and Pre-Sub submissions, IVD method validations and QMS development (EN ISO 13485). Internal audits according to ISO 13485, USFDA QSR and MDSAP.

• 

  Labquality

  Aug 2017 - now

  Regulatory strategies for medical device and in vitro diagnostic medical device manufacturers. 510(k) submissions and Pre-Sub submissions, clinical evaluations, IVD method validations and QMS development (EN ISO 13485, USFDA QSR, Canadian MDR). Internal audits according to ISO 13485, USFDA QSR and MDSAP.

  • Quality and Regulatory Affairs Manager

    Nov 2020 - now

  • Quality and Regulatory Affairs Manager

    Aug 2017 - now