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

Echopoint Medical Ltd; Greater London; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A medical device start-up in Greater London is seeking a full-time Regulatory Affairs Manager for US FDA Submission. The role coordinates the 510(k) regulatory submission, ensuring compliance with regulations, and requires strong skills in regulatory affairs, quality system management, and technical documentation preparation. Candidates should possess a related scientific degree and effective teamwork and communication abilities. The position allows for some remote work during the 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.
• Familiarity with US FDA guidelines and processes.

Responsibilities

• Coordinate and manage 510(k) regulatory submission for US FDA market clearance.
• Ensure compliance with applicable regulatory standards and requirements.
• Prepare and submit technical documentation.
• Liaise with regulatory authorities.
• Collaborate with quality and development teams.
• Provide regulatory guidance throughout product development.

Skills

Regulatory Compliance

Regulatory Affairs

Quality System management

Technical documentation preparation

Analytical skills

Problem-solving skills

Communication

Teamwork

Organizational abilities

Education

Bachelor's or higher degree in a related scientific, engineering, or technical field

Job description

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