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- Tasks: Manage regulatory documentation for AI medical devices and support product teams with compliance.
- Company: Leading company in AI medical technology with a focus on innovation.
- Benefits: Attractive salary, flexible working options, and opportunities for professional growth.
- Why this job: Join a pioneering team shaping the future of healthcare technology.
- Qualifications: Degree in a relevant field and five years in medical device regulation.
- Other info: Collaborative environment with a strong emphasis on continuous improvement.
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 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
✨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 in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of AI-enabled devices and current regulations. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise!
✨Tip Number 3
Showcase your skills through real-life examples. When discussing your experience, we suggest using the STAR method (Situation, Task, Action, Result) to clearly demonstrate how you've tackled challenges in the regulatory space.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team!
We think you need these skills to ace AI Medical Devices Regulatory Officer
Some tips for your application 🫡
Show Off Your Organisational Skills: When you’re writing your application, make sure to highlight your ability to keep things organised and searchable. We love candidates who can maintain technical files and ensure documentation is current and consistent, so give us examples of how you've done this in the past!
Tailor Your Experience: Don’t just send a generic application! Make sure to tailor your experience to match the job description. If you’ve worked with AI-enabled software medical devices or have knowledge of regulatory pathways in the US, EU, or UK, let us know. We want to see how your background fits with what we do!
Be Clear and Concise: We appreciate clarity! When writing your application, be clear and concise. Use straightforward language and structure your documents well. This not only shows off your digital skills but also makes it easier for us to see why you’d be a great fit for the role.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to submit all the necessary documents in one go. Plus, it helps us keep track of your application better!
How to prepare for a job interview at Odin Vision Ltd
✨Know Your Regulations
Familiarise yourself with the latest regulations and standards for AI medical devices, especially those relevant to the US, EU, and UK. Being able to discuss these in detail will show your expertise and readiness for the role.
✨Showcase Your Documentation Skills
Prepare examples of how you've organised and maintained technical files or documentation in previous roles. Highlight your ability to keep things current and retrievable, as this is crucial for the position.
✨Engage with Risk Management
Be ready to discuss your experience with risk management activities. Think of specific instances where you contributed to risk assessments or post-market surveillance, as this will demonstrate your practical knowledge.
✨Communicate Effectively
Practice articulating complex regulatory concepts clearly and concisely. You'll need to interact with various stakeholders, so showcasing your communication skills during the interview will be key to making a great impression.
