Study Director Clinical Reprocessing

For our well-known client in Oberdorf we're looking for a Study Director Clinical Reprocessing for a 7 months project.

Role: Study Director Clinical Reprocessing
Location: Oberdorf
Duration: 01.06.2017 - 31.12.2017
Workload: 100%

The person employed in this role will be responsible for the verification of product quality requirements with regards to resistance to degradation.

Responsibilities:
* Review product designs and manufacturing specifications to define product families and respective worst case representatives.
* Coordinate required product testing at our internal lab and document and rationalize verification results for the product families.
* Collaborate with the product development, design quality and test lab teams as well as manufacturing engineering to facilitate timely results.
* Information exchange and collaboration between internal, local, external and foreign partners is essential.
* Close cooperation with internal departments, domestic and international authorities as well as the conscientious preparation of the required documents ensures compliance with Medical Device Regulations (EU MDD, US FDA, JP PAL).

Education/Experience:
* Degree in Engineering or Natural Sciences and preferably some practical experience in a regulated industry.
* Self-motivated, systematic problem-solver with excellent communication skills
* Ability to take responsibility on projects.
* Keen interest in the interrelations between medicine and technology and a strong desire to work in a global company.
* Ability to communicate in both spoken and written English is required.
* Communication skills in German are highly preferred.

Must have:
. Microsoft Office incl. Outlook, Word, Excel, Powerpoint, Access and IE
. Fluent English
. Documentation Expertise
. Medical devices experiences
. Minitab