We currently have a staffing opportunity for a new medical device consultant.

Responsibilities
-    Consult with medical device manufactures, assist with the implementation of the European Medical Device Directives requirements for all risk classifications , assisting with the compilation of a technical file in order to obtain the CE-mark.
-    Consult during the implementation of  ISO 13485:2003 quality management systems for medical devices.
-    Prepare annually desk review of technical documents.
-    Keep up-to-date on changes to EU-Medical Directives and related standards.

Requirements
-    Minimum of 5 years experience with medical device manufacturing or in health care services.
-    Knowledge and experience with ISO quality standards (ISO 9001 / ISO 13485)
-    Minimum education: bachelor degree in medical or technical science
Written and verbal fluency in Dutch and English.

Desired:
-    Experience as quality / regulatory affairs manager in the medical device industry, certification body, governmental departments or health care services.
-    Completed training as (lead) auditor in Medical Devices Directives or quality standards
-    International experience
-    Age: 25 – 40 years

We offer:
-    Substantial Dutch and American client base.
-    Nicely situated offices near the National Park and easily accessed from NS-station (about 5 min.) and highway.
-    Interaction with our Dutch and American team members.
-    New consultancy opportunities in other area’s like Eastern Europe and Asia


To apply, please submit a resume and cover letter to Dit e-mail adres is beschermd door spambots, u heeft Javascript nodig om dit onderdeel te kunnen bekijken

CEpartner4U BV
Maarn, February 2008