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- Tasks: Manage regulatory documentation for AI medical devices and support cross-functional teams.
- Company: Leading company in AI medical technology with a focus on innovation.
- Benefits: Attractive salary, health benefits, flexible working options, and career development opportunities.
- Why this job: Join a pioneering team shaping the future of healthcare technology.
- Qualifications: Degree in a relevant field and five years of regulatory experience required.
- Other info: Dynamic role with opportunities to influence global regulatory strategies.
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 (FSCA), 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
Contact Detail:
Odin Vision 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 when it comes to landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of AI-enabled devices and relevant 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 practical examples. When discussing your experience, highlight specific projects where you’ve contributed to regulatory activities or risk management. We want to see how you’ve made an impact!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace AI Medical Devices Regulatory Officer
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the AI Medical Devices Regulatory Officer role. Highlight your relevant experience in regulatory activities and any specific knowledge of UK, EU, and US pathways. We want to see how your background aligns with our needs!
Showcase Your Skills: Don’t forget to emphasise your strong digital skills! Mention your experience with documentation tools and eQMS, as well as your ability to produce well-structured documents. This is key for us when reviewing applications.
Be Clear and Concise: When writing your application, keep it clear and to the point. Use bullet points where possible to make it easy for us to read through your qualifications and experiences. We appreciate a straightforward approach!
Apply Through Our Website: Finally, make sure to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at Odin Vision
✨Know Your Regulations
Make sure you brush up on the latest regulations and standards for AI medical devices, especially those relevant to the US, EU, and UK. Being able to discuss these confidently will show that you're not just familiar with the basics but are also proactive about staying updated.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully navigated regulatory processes or contributed to technical documentation. This will help demonstrate your hands-on experience and how it aligns with the responsibilities of the role.
✨Engage with Technical Teams
Be ready to discuss how you would collaborate with engineering, AI/ML, and clinical design teams. Highlight any previous experiences where you provided regulatory advice or support, as this will illustrate your ability to work cross-functionally.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's portfolio and their approach to regulatory challenges in AI-enabled devices. This shows your genuine interest in the role and helps you gauge if the company is the right fit for you.
