RA Specialist

Selexa Life Sciences are delighted to partner with a leading Medical Device manufacturer in the search for a Regulatory Affairs Specialist to join their high-performing RA team based onsite in Cheltenham.

Reporting into the Group Regulatory & Quality Director, as an RA Specialist you will be responsible for the assurance of our client's device adherence and compliance to industry standards and regulations.

Role Responsibilities:

As an RA Specialist, you will be responsible for:

• Working closely with the Group RA Manager to manage Notified Body requests, Competent Authorities and country-specific regulatory agencies globally
  
  
• Support internal and external auditing process to ensure proess confirmity and ensure our client's product range adheres to regulations
  
  
• Responsible for Technical File update and maintenance in line with specific requirements
  
  
• Work closely with RA Manager for Technical Documentation, QMS and adherence to regulatory guidlines
  
  
• Ensure consistent and regular updates for device compliance, clinical evaluation and relevant/required follow up
  
  
• A strong working knowledge of QMS, Risk Management and global device knowledge, as well as CAPA management experience
  
  Skills and Qualifications:
  
  
• Degree in Biomedical Engineering, Life Sciences or Engineering discipline
  
  
• 2-5 years QARA knowledge within medical device sector – ISO13485
  
  
• Knowledge of Clinical Evaluations, Tech Files, MDR 2017, and Post Market working knowledge