Kirsten Van Garsse

Regulatory Affairs Manager & Director Authorized Representative Operations

Kirsten Van Garsse joined Qarad at the end of 2017. Kirsten obtained her Master’s degree in Biomedical Sciences in 2002 from the Vrije Universiteit Brussel (VUB) and has gained extensive experience working in the In Vitro Diagnostic Medical Device Industry in various roles.

As a Regulatory Affairs Manager within Qarad, Kirsten applies her experience for Regulatory Affairs projects, translating regulations into compliant business processes and applications.
She also actively gathers all relevant regulatory intelligence and writes the company newsletters.

As Director Authorized Representative Operations she is responsible for the representation of non-EU IVD and MD manufacturers based in the US, Asia and Australia (product notifications, cooperation with competent authorities on vigilance cases, provision of legalized certificates of free sales).

Her expertise includes i.e.:

Regulatory Compliance
(IVD Directive 98/79/EC and IVDR 2017/746)
Writing Scientific Validity Reports including systematic literature review
Complaint Management
Development of an efficient cross regional Complaint Management System and procedures as well as functioning as SAP Business Process Owner for the complaint management tool
Vigilance Reporting in accordance with MEDDEV Guidelines
Development of an EMEA Regulatory Strategy for entire product pipeline in collaboration with sales and marketing
Product Management
Product lifecycle management from product launch to product discontinuation
Managing cross functional and cross-regional projects

Kirsten Van Garsse

Regulatory Affairs Manager & Director Authorized Representative Operations

QARAD B.V.B.A.

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Kirsten Van Garsse

Regulatory Affairs Manager & Director Authorized Representative Operations

QARAD B.V.B.A.

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