Regulatory Affairs Specialist

For our well-known client in Solothurn we're looking for a Regulatory Affairs Specialist for a 6 months project.

Role: Regulatory Affairs Specialist
Location: Solothurn
Duration: 19.06.2017 - 31.12.2017
Workload: 100%

Responsibilities:
Support the internal Regulatory Affairs group in creation and maintenance of Technical File documentation according to Council Directive 92/42/EEC:
. Creation, review and maintenance of regulatory related technical documentation
. Capturing and verification of regulatory product characteristics to support logistic and supply chain efforts on a global scale
. Providing Regulatory input and support for upcoming MDR revision

Requirements:
. Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
. Knowledge of FDA regulations and registration requirements in further global markets would be an asset
. 2-3 years of experience in European Medical device industry especially with regulatory, quality or engineering
. Familiarity with Technical Documentation structure according to STED required
. Experience in projects related to Supply Chain and Logistics would be an asset
. Excellent skills in computer software such as MS Word, Excel, Powerpoint
. Strong Database skills
. Strong analytical skills and network thinking
. Excellent English spoken and written, German is an asset

Must Have:
. Fluent English
. Knowledge of MDD 93/42/EEC
. Medical devices experience
. RA (Regulatory Affairs) experience

Additional requirements:
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision
- Quick learner, motivated self-starter
- Excellent customer service, interpersonal, communication and team collaboration skills
- Able to follow change management for internal guidelines