Anja Wiersma

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Dr. Wiersma, is a medical biologist by training with a PhD in the Neuropharmacological –Behavioral – Physiology field. After working for 8 years at a multinational pharmaceutical company (Organon), first as scientific researcher and later as a Strategist in Strategy and Business Development department, she started to work for a Notified Body in the field of Medical Devices and In Vitro Diagnostic Medical Devices. She was working for this notified body for 6.5 year and in the last period Certification Manager for the IVDD as well.
She is fully qualified as a notified body auditor for the Medical Device Directive (MDD 93/42/EEC), Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Device Directive (IVDD 98/79/EC) as well as the future In Vitro Diagnostic Device Regulation (IVDR EU 2017/746).

Since 2010 she is a RA/QA consultant for medical device and in vitro diagnostic device manufacturers, and she remains a contractor for several notified bodies executing design dossier reviews and CE audits as well as for executing inspections for independent organisations.
From Jan 2013 until Aug 2015 she had a part time position as QA/RA director and was part of management team of an IVD company in the Netherlands.

Since March 2015 she is member of the board of the RAPS Netherlands Chapter. RAPS is Regulatory Affairs Professional Society. As of March 2017, she became the chair of the board of the RAPS Netherlands Chapter.

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