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- Tasks: Lead regulatory strategies for AI-driven medical software and ensure compliance with global standards.
- Company: Innovative healthcare tech company focused on AI and software as a medical device.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Join a dynamic team dedicated to advancing healthcare technology.
- Why this job: Make a real impact in healthcare by ensuring cutting-edge technologies meet regulatory standards.
- Qualifications: Experience in Regulatory Affairs with a focus on SaMD and strong communication skills.
The predicted salary is between 60000 - 80000 £ per year.
We are looking for a Senior Regulatory Affairs Specialist to support the regulatory strategy and compliance activities for AI-enabled software products used within clinical and healthcare environments. This position will play a key role in ensuring products meet international regulatory and quality standards across the UK, EU and US markets.
The role will involve leading regulatory submissions and maintaining compliance for Software as a Medical Device (SaMD) and AI-based technologies, while working closely with cross-functional teams including Quality, Engineering, Product, Clinical Operations and Data Science. You will provide regulatory guidance throughout the software development lifecycle, including validation activities and risk management processes.
Key responsibilities include:
- Developing and implementing regulatory strategies for software and AI-driven medical technologies
- Supporting global regulatory submissions and interactions with notified bodies, auditors and regulatory authorities
- Ensuring compliance with relevant standards and regulations including ISO 13485, IEC 62304, ISO 14971 and AI/ML guidance
- Reviewing technical documentation, risk management files and validation documentation
- Supporting audits, inspections and quality management activities
- Monitoring regulatory developments and advising internal teams on compliance requirements
The ideal candidate will have:
- Significant experience within Regulatory Affairs focused on SaMD and AI-based healthcare technologies
- Strong knowledge of global medical device regulations and quality standards
- Experience supporting software validation and regulated development environments
- Excellent stakeholder management and cross-functional communication skills
- A degree in a scientific, engineering or technical discipline
If you are interested in finding out more, click apply now.
Senior Regulatory Affairs Manager in London employer: SciPro
Contact Detail:
SciPro Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Manager in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those who work with SaMD and AI technologies. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO standards and regulatory compliance. We recommend creating a list of common interview questions related to regulatory affairs and practising your responses with a friend or mentor.
✨Tip Number 3
Showcase your experience with cross-functional teams! Be ready to discuss how you've collaborated with Quality, Engineering, and Clinical Operations in past roles. This will demonstrate your ability to work effectively in a team-oriented environment.
✨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 Senior Regulatory Affairs Manager in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Regulatory Affairs, especially with SaMD and AI technologies. We want to see how your skills align with the key responsibilities mentioned in the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory compliance in healthcare tech. We love seeing genuine enthusiasm for the role and our mission.
Showcase Your Experience: When detailing your past roles, focus on specific achievements related to regulatory submissions and compliance. We’re keen to know how you’ve navigated challenges in previous positions.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re serious about joining our team!
How to prepare for a job interview at SciPro
✨Know Your Regulations
Make sure you brush up on the key regulations and standards mentioned in the job description, like ISO 13485 and IEC 62304. Being able to discuss these confidently will show that you’re not just familiar with them, but that you can apply this knowledge practically.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully led regulatory submissions or navigated compliance challenges. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them impactful.
✨Cross-Functional Collaboration
Since the role involves working closely with various teams, think of instances where you’ve effectively collaborated with engineering, clinical operations, or data science teams. Highlight your communication skills and how you’ve managed stakeholder expectations.
✨Stay Updated on Trends
Research recent developments in AI and SaMD regulations. Being able to discuss current trends or changes in the regulatory landscape will demonstrate your commitment to staying informed and your proactive approach to regulatory affairs.