Regulatory Affairs Manager - US FDA Submission (12 month contract)

Echopoint Medical Ltd

London

3 months ago

Applications closed

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Company Description

Echopoint Medical Ltd. is a dynamic medical device start-up based in London, UK, originating from University College London. We are developing the iKOr system which provides coronary flow data to interventional cadiologists in a simple way to enable better diagnosis of coronary microvascular disease. Our innovative optical sensors and advanced algorithms aim to transform the treatment of INOCA (Ischaemia with Non-Obstructive Coronary Artery) syndrome by improving patient outcomes, reducing complications, and lowering costs. Our dedicated team comprises a diverse group of engineers, clinicians, and management, all driven by a shared mission to create a positive clinical impact.

Role Description

This is a full-time hybrid position for a Regulatory Affairs Manager - US FDA Submission. The role involves coordinating and managing our 510(k) regulatory submission for US FDA market clearance, ensuring compliance with applicable regulatory standards and requirements. Responsibilities include preparing and submitting technical documentation, liaising with regulatory authorities, collaborating with the quality and development teams, and providing regulatory guidance throughout product development as well as working with our US based Regulatory Affairs Consultant. The position is based in Greater London, with the flexibility of some remote work during the 12-month contract period.

Qualifications

Expertise in Regulatory Compliance and understanding of relevant Regulatory Requirements
Experience in Regulatory Affairs, including planning and managing Regulatory Submissions
Knowledge of Quality System management within the medical device industry
Proficiency in preparing technical documentation for FDA submissions
Strong analytical and problem-solving skills
Bachelor’s or higher degree in a related scientific, engineering, or technical field
Familiarity with US FDA guidelines and processes
Effective communication, teamwork, and organizational abilities

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