At a Glance
- Tasks: Lead regulatory strategies for AI-driven medical software and ensure compliance with global standards.
- Company: Join a pioneering company at the forefront of healthcare technology.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Collaborative environment with a chance to work on cutting-edge technologies.
- Why this job: Make a real difference in healthcare by ensuring innovative products 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 Manager, Data Management in City of 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 extensive training opportunities and a collaborative work culture that encourages cross-functional teamwork. Located in the UK, our team thrives on making a meaningful impact in the healthcare sector while enjoying a supportive environment that values work-life balance and professional growth.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Data Management in City of 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. Use platforms like LinkedIn to connect and engage with them; you never know who might have a lead on your dream job!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO standards and regulatory compliance. Be ready to discuss how you've navigated these in past roles. We want to see your expertise shine through!
✨Tip Number 3
Showcase your cross-functional collaboration skills! In your conversations, highlight experiences where you've worked with teams like Quality, Engineering, or Clinical Operations. This will demonstrate your ability to thrive in a multidisciplinary 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 Manager, Data Management in City of London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Senior Regulatory Affairs Manager. Highlight your experience with SaMD and AI technologies, and don’t forget to mention any relevant regulatory standards you’ve worked with.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention specific projects or experiences that align with the responsibilities listed in the job description.
Showcase Your Cross-Functional Skills:Since this role involves working closely with various teams, make sure to highlight your cross-functional communication skills. Share examples of how you've successfully collaborated with different departments in the past.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and get to know you better!
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.
