At a Glance
- 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 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 / Manager, Regulatory Affairs 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 Regulatory Affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager / Manager, Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to professionals in Regulatory Affairs 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 SaMD and AI regulations. We recommend creating a cheat sheet of key standards like ISO 13485 and IEC 62304 to impress your interviewers.
✨Tip Number 3
Showcase your experience with real-life examples during interviews. We love hearing about specific projects where you’ve led regulatory submissions or navigated compliance challenges—make it memorable!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always on the lookout for passionate candidates who fit our culture.
We think you need these skills to ace Senior Manager / Manager, Regulatory Affairs
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, highlight any experience you have in cross-functional collaboration. We value strong communication skills, so don’t forget to mention how you've effectively worked with different departments.
Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. It helps us keep track of your application and ensures you’re considered for the role without any hiccups!
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. Highlighting your stakeholder management skills will demonstrate your ability to work well in a team-oriented environment.
✨Stay Updated on Trends
Regulatory affairs is constantly evolving, especially with AI technologies. Be prepared to discuss recent developments in the field and how they might impact regulatory strategies. This shows your passion for the industry and your proactive approach to staying informed.
