Beschreibung
Risk Manager(medical devices background a must)
Overall Responsibilities:
Risk Management documentation to the Product Risk Management Process of:
- Risk Management Plan
- Design & Clinical Risk Management
- Risk Management Report
Functional Experience Requirements
- Strong background in Product Risk Management with experience in creation, review, and approval of risk management documentation (DFMEAs and PFMEAs)
- Experienced in ISO 14971
- Two or more years' experience in the design and development of medical devices or pharmaceuticals preferred.
- Strong analytical skills.
- Practical experience in a medical device Regulatory Environment, preparing Design Dossier submissions and preparation of Technical Files is beneficial
- Knowledge of European Medical Device regulations is preferred; in addition, knowledge of US medical device regulations is beneficial
Required Degree/Certificates:
- BS in Engineering (or science) required
Competencies:
- Proficient in Microsoft Office (Excel, Word, etc.).
- Ability to work as a member of a team in a timeline-driven environment with limited supervision is required
- Being detail-oriented while having the ability to handle multiple ongoing projects/tasks is required.
- Specific Languages: * Fluently in German and English
If you are interested in this or a similiar position please send me your updated CV to my email address:
I am looking forward hearing back from you and wishing you a great week ahead.
Kind Regards,
Marco Tvrdon
Recruitment Consultant
m.tvrdon(a)realstaffing.com
Tel.:
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.