At a Glance
- Tasks: Lead regulatory strategies for AI-driven medical software and ensure compliance with global standards.
- Company: Innovative healthcare technology firm focused on AI and software solutions.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and career advancement.
- Why this job: Make a real impact in healthcare by ensuring cutting-edge technologies meet regulatory standards.
- Qualifications: Experience in Regulatory Affairs for SaMD and strong knowledge of medical device regulations.
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 Manager Regulatory Affairs in London employer: SciPro
Join a forward-thinking company that prioritises innovation and compliance in the rapidly evolving field of AI-enabled healthcare technologies. With a strong commitment to employee development, we offer a collaborative work culture that encourages professional growth and provides opportunities to lead impactful regulatory strategies. Located in the UK, our team thrives on diversity and creativity, making it an excellent place for those seeking meaningful and rewarding employment in the regulatory affairs sector.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Regulatory Affairs in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those working with SaMD and AI technologies. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Showcase your expertise! Prepare a portfolio that highlights your experience with regulatory submissions and compliance activities. This can be a great conversation starter during interviews and helps us see your skills in action.
✨Tip Number 3
Stay updated on regulations! Keep an eye on the latest developments in medical device regulations and quality standards. Being knowledgeable about ISO 13485 and IEC 62304 will impress potential employers and show you're serious about the role.
✨Tip Number 4
Apply through our website! We love seeing applications directly from candidates who are passionate about regulatory affairs. It shows initiative and gives you a better chance of standing out in the hiring process.
We think you need these skills to ace Senior Manager Regulatory Affairs 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 background aligns 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 candidates who can connect their personal motivations to our mission.
Showcase Your Cross-Functional Skills:Since this role involves working with various teams, be sure to mention any experience you have in collaborating with Quality, Engineering, or Clinical Operations. We value strong communication skills and teamwork!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people!
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've successfully navigated regulatory submissions or compliance activities. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your achievements.
✨Cross-Functional Collaboration
Since the role involves working closely with various teams, think of instances where you’ve effectively collaborated with different departments. Be ready to discuss how you managed stakeholder expectations and facilitated communication between teams.
✨Stay Updated on Trends
Regulatory affairs is a fast-evolving field, especially with AI technologies. Make sure you’re aware of the latest developments and trends in SaMD and AI regulations. This will not only impress your interviewers but also demonstrate your commitment to staying informed in your field.
