Johnson & Johnson
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