Regulatory Affairs Specialist

Regulatory Affairs Specialist

Located in Leeds

12 month contract initially 

Responsibilities:

• Support the internal Global Strategic Implementation Group:

• Support product registrations in line with agreed project lines

• Capturing and verification of regulatory product characteristics to support logistic and supply chain efforts on a global scale

• Prepare and submit regulatory documentation with support from Regulatory Manager as required

Technical Documentation structure according to STED required

• Handling incoming and outgoing correspondence

• Management of Purchase Orders

Experience: 

•  University Degree or higher

• 2-3 years’ experience in European Medical device industry especially with regulatory, quality or engineering

• Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC

desirable

• Knowledge of FDA regulations and registration requirements in further global markets would be an asset

• Familiarity with Technical Documentation structure according to STED required

• Experience in projects related to Supply Chain and Logistics is a plus

• Excellent skills in computer software such as MS Tools

• Strong Database skills

• Strong analytical skills and network thinking