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, Contracts Management in City of London employer: SciPro
As a leading employer in the healthcare technology sector, we offer a dynamic work environment that fosters innovation and collaboration. Our commitment to employee growth is reflected in our comprehensive training programmes and opportunities for advancement within the company. Located in the UK, we provide a supportive culture that values diversity and encourages employees to contribute to meaningful projects that improve patient outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Contracts Management in City of London
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Senior Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO standards and AI regulations. We recommend creating a cheat sheet of key points to discuss, so you can impress the interviewers with your expertise!
✨Tip Number 3
Showcase your experience with SaMD and AI technologies during interviews. We suggest using specific examples from your past roles to demonstrate how you’ve successfully navigated regulatory challenges.
✨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, Contracts 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 passionate about regulatory affairs in healthcare and how your background makes you the perfect fit for our team at StudySmarter.
Showcase Your Cross-Functional Skills:Since this role involves working closely with various teams, make sure to highlight your experience in cross-functional collaboration. Share examples of how you’ve successfully communicated and worked with different departments.
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 can also apply them in real-world scenarios.
✨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 trends and developments in SaMD and AI regulations. This will not only impress your interviewers but also demonstrate your commitment to staying informed in your field.
