Regulatory Affair Specialist - Leeds (Hybrid)

Regulatory Affair Specialist - Leeds (Hybrid) 

You will be required to visit site (Leeds) once or twice a week minimum. 

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

DePuy Synthes is part of Johnson & Johnson and the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials.

Duties and 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
• Handling incoming and outgoing correspondence
• Management of Purchase Orders

Professional Experience Required:

•  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#

In Return:

In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 

Things to remember before applying for this role:

• This role is INSIDE IR35. The pay rate for this role will depend on how you are paid (PAYE or Umbrella options).
• We are looking to process the first round of applications within the next 2 working days.
• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, you’re personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application. 

If you would like some additional information about the role please contact: Tabitha.crabtree@randstadsoruceright.co.uk