Stephanie Valk

PMS Vigilance expert

Stephanie Valk, MSc.
Senior Consultant

Prior to Qserve, Stephanie was Manager Regulatory Affairs & Quality Assurance EMEA at an international company in Orthopedics devices. She also worked for a Notified Body as lead auditor medical devices. Stephanie has a Master degree in Human Movement Science (MSc).

Stephanie has almost 10 years’ experience in Quality Management Systems (e.g. ISO 13485 & Quality System Regulations).
She has been responsible for the management of Regulatory submissions for different regions in the world (e.g. EU, Middle East, Russia) for an international medical device company. She has solid knowledge of global medical device requirements in relation to new product developments, post-market surveillance and timely marketability.
She uses her Project management capabilities to interface with management, sales teams, sales channels, supply chain.

 

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