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- Tasks: Manage regulatory documentation for AI medical devices and support product development teams.
- Company: Leading company in AI medical technology with a focus on innovation.
- Benefits: Attractive salary, health benefits, flexible working options, and career advancement opportunities.
- Why this job: Join a pioneering team shaping the future of healthcare technology.
- Qualifications: Degree in a relevant field and experience in medical device regulations.
- Other info: Dynamic role with opportunities to engage with international markets and cutting-edge AI developments.
The predicted salary is between 36000 - 60000 £ per year.
AI Medical Devices Regulatory Officers shall carry out the following list of non-exhaustive activities:
- Author and maintain technical files in an organized and searchable way, ensuring documentation is current, consistent, and readily retrievable for submissions, updates, and external review.
- Provide support for assigned AI-enabled software medical devices (SaMD) within the Company's portfolio of products, including but not limited to advice to engineering, AI/ML and clinical design teams on regulatory considerations for new products, features or changes.
- Support regulatory activities across international markets relevant to the Company's portfolio, including but not limited to the US, EU and UK.
- Participate in risk management activities.
- Support post-market surveillance (PMS) activities, including vigilance reporting, Field Safety Corrective Actions (FSCAs), and Periodic Safety Update Reports (PSURs), as needed.
- Support clinical evaluation activities and associated documentation (e.g., evidence collection, updates to clinical evaluation documentation, and claims substantiation).
- Maintain the list of registered devices and actors involved in the regulatory processes.
- Maintain the labelling register and support the review of labelling material including marketing claims, ensuring alignment with intended use and clinical evidence.
- Periodically assess the contents of Design History Files.
- Perform regular reviews of regulations, international standards and guidelines to highlight gaps and/or opportunities for continuous improvement of relevant technical documentation and the QMS, as well as support implementation with the subject specialists.
- Support the implementation and maintenance of the quality management system (QMS) in line with regulatory approvals and markets of interest for the Company's software products.
- Interact with external parties, such as regulators, auditors, notified bodies, EUAR, end users, patients and external consultants on regulatory matters.
Desirable Qualifications
- Undergraduate degree in a relevant scientific or technical subject (e.g. software, biomedical engineering, biomedical sciences or similar).
- Qualification for the implementation of relevant regulatory standards and regulations (EU, UK, US).
Experience
- A minimum of five years working in the medical device regulatory industry.
- Knowledge of UK, EU and USA regulatory pathways, with practical experience supporting US regulatory activities strongly preferred.
- Experience or interest in topics relevant to AI-enabled devices, such as emerging AI regulation (e.g., EU AI Act) and/or cybersecurity/security considerations for medical devices/software.
- Strong digital skills are essential, including producing well-structured documents, maintaining trackers, and working efficiently with common documentation and collaboration tools, as well as an eQMS.
AI Medical Devices Regulatory Officer in London employer: Odin Vision Ltd
Contact Detail:
Odin Vision Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land AI Medical Devices Regulatory Officer in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device regulatory field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be when it comes to landing that dream job.
✨Tip Number 2
Show off your expertise! Prepare to discuss your experience with AI-enabled devices and regulatory pathways during interviews. We want you to highlight your knowledge of UK, EU, and US regulations to impress potential employers.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your responses. We recommend focusing on your problem-solving skills and how you've tackled challenges in previous roles.
✨Tip Number 4
Apply through our website! We’ve got a streamlined application process that makes it easy for you to showcase your skills. Don’t miss out on opportunities by applying elsewhere; we want to see your application!
We think you need these skills to ace AI Medical Devices Regulatory Officer in London
Some tips for your application 🫡
Show Your Organisational Skills: As an AI Medical Devices Regulatory Officer, you'll need to keep everything organised and up-to-date. Make sure your application reflects your ability to manage documentation effectively. Use clear headings and bullet points to make it easy for us to see your skills in action!
Highlight Relevant Experience: We want to see your experience in the medical device regulatory industry shine through. Be specific about your past roles and how they relate to the responsibilities listed in the job description. This will help us understand how you can contribute to our team right from the start.
Demonstrate Your Digital Skills: Strong digital skills are a must for this role. In your application, mention any tools or software you've used to create documents, maintain trackers, or collaborate with teams. This shows us you're ready to hit the ground running with our tech!
Tailor Your Application: Don't just send a generic application! Tailor your CV and cover letter to match the job description. Use keywords from the listing to show us you understand what we're looking for. And remember, applying through our website is the best way to get noticed!
How to prepare for a job interview at Odin Vision Ltd
✨Know Your Regulations
Familiarise yourself with the latest UK, EU, and US regulatory pathways for medical devices. Be prepared to discuss how these regulations impact AI-enabled software medical devices, as this will show your understanding of the industry and its challenges.
✨Showcase Your Technical Skills
Highlight your experience in authoring technical files and maintaining documentation. Bring examples of how you've organised and updated regulatory submissions in the past, as this will demonstrate your attention to detail and organisational skills.
✨Engage with Real-World Scenarios
Prepare to discuss specific scenarios where you supported regulatory activities or participated in risk management. This could include your role in post-market surveillance or clinical evaluation activities, showcasing your practical experience in the field.
✨Communicate Clearly
Practice articulating complex regulatory concepts in a straightforward manner. Since you'll be interacting with various stakeholders, including engineers and external regulators, clear communication is key to ensuring everyone is on the same page.
