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Job Reference: SC/HQ1326

Regulatory Affairs Manager

  • London, Greater London, England
  • Permanent / Full Time
  • Life Sciences Team
  • £50000 - £60000

Regulatory Affairs Manager

The Company

  • An exciting medical device therapeutics start-up developing “magnetic blood filtration”, a revolutionary treatment for blood-borne diseases which removes pathogens directly from the bloodstream
  • Our technology is like dialysis, circulating a patient’s blood through an external circuit to remove disease causing targets
  • While dialysis relies on non-specific size-based filtration, uses magnetic beads coated with antibodies to target specific components, and magnetic forces to extract them
  • Our initial target diseases are malaria, sepsis and leukaemia.

Role

  • As Regulatory Affairs Manager, you will manage drafting the company’s regulatory documentation, as well as managing our Technical Files and Contractors
  • You will work directly with our technical team and highly experienced Contractors to help bring each product through the medical device regulatory pathway
  • This is an exciting opportunity to join an award-winning, ambitious start-up in which you can have a real impact during an exciting stage of development
  • In addition to a competitive salary, the company operates a stock option plan for its employees
  • The post is a full-time, permanent appointment, subject to a performance-based probation period of 6 months

Essential Experience

  • BSc/MSc in Life Sciences or relevant degree
  • Excellent knowledge of EU Medical Device Regulations
  • At least 3 years of relevant experience in industry
  • Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
  • Good knowledge of relevant ISO standards (e.g. 13485, 10993, 14971…).
  • Experience writing regulatory documentation, including risk assessments, technical files and design history files.
  • Ability to work independently to manage and prioritise workload, and also work collaboratively as part of a team.

Desired Experience

  • Assistance in compiling documentation for clinical trials
  • Correspondence with MHRA
  • Writing strong rationale documents
  • Knowledge of devices/therapies using antibodies
  • Biological and toxicological evaluations

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