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Regulatory Affairs Assistant

North West, United Kingdom

  • Salary: Up to £180 Per Day
  • Job type: Interim/Contract
  • Posted: 11/12/2018

Job description

Hobson Prior is currently seeking a RA Assistant, to join a leading life science Medical device company based in the North West.

Position Responsibilities 
 
• Provide full support to the Regulatory Project Leader to ensure that all aspects of the registration programme are conducted in accordance with the requirements of the company and the regulators. 
• Provide support to the US for FDA submissions. 
• Facilitate the product registration activities in Europe by compiling appropriate dossiers, submissions and responses to regulatory bodies. 
• Maintain processes for submissions, interim notifications and periodic re-submissions. 
• Maintain information on regulatory requirements and the status of product registrations. 
• Liaise with product development groups, marketing and sales to co-ordinate timely approvals. 
• Provide support and advice to worldwide company colleagues, particularly product development, marketing and sales, concerning international regulatory requirements in Europe. 
• Establish relationships with country personnel, regulatory bodies and appropriate company personnel to expedite the product registration process. 

Non Essential Functions: 
• Establish relationships with country personnel, regulatory bodies and appropriate company personnel to expedite the product registration process. 
• Provide information and support as appropriate to world-wide company colleagues 
 
 Experience Required 
• Degree or equivalent preferred (Or relevant experience) 
• Forward planning, organisational and time management skills 
• Ability to use own initiative, speedily and efficiently handle enquiries and requests 
• Work to tight deadlines and remain calm in stressful situations 
• Good knowledge of MS Office products, such as Excel, Outlook and Word essential