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Regulatory Affairs Manager posted by Seven Resourcing

Applications close in 3 days
£50,000 - £60,000 / year

Job Description

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.

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

Reference Number


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