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
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CEpartner4U BV
Maarn, February 2008
