At a Glance
- Tasks: Lead regulatory submissions and ensure compliance for AI-enabled medical software.
- Company: Innovative healthcare tech company focused on AI and software solutions.
- Benefits: Competitive salary, flexible working hours, 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 global standards.
- Qualifications: Experience in regulatory affairs and knowledge of medical device regulations.
The predicted salary is between 60000 - 80000 £ per year.
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
Senior Regulatory Affairs Manager employer: SciPro
As a leading player in the healthcare technology sector, our company offers an exceptional work environment for a Senior Regulatory Affairs Manager. We pride ourselves on fostering a collaborative culture that encourages innovation and professional growth, providing employees with opportunities to lead impactful projects in AI-enabled software for clinical applications. Located in a vibrant area, we offer competitive benefits, flexible working arrangements, and a commitment to continuous learning, making us an attractive employer for those seeking meaningful and rewarding careers in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Manager
✨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 that could lead to job opportunities.
✨Tip Number 2
Showcase your expertise! Prepare a portfolio that highlights your experience with regulatory submissions and compliance activities. This will help you stand out during interviews and demonstrate your value to potential employers.
✨Tip Number 3
Stay updated on regulations! Keep an eye on the latest developments in ISO standards and AI/ML guidance. Being knowledgeable about current trends will not only boost your confidence but also impress interviewers.
✨Tip Number 4
Apply through our website! We’ve got a dedicated section for job openings where you can find roles that match your skills. It’s a great way to ensure your application gets noticed by the right people.
We think you need these skills to ace Senior Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Regulatory Affairs Manager role. Highlight your experience with SaMD and AI technologies, and don’t forget to mention any relevant regulatory submissions you've led!
Showcase Your Skills:In your cover letter, showcase your skills in developing regulatory strategies and compliance activities. We want to see how you’ve navigated international regulations and worked with cross-functional teams.
Be Specific:When detailing your past experiences, be specific about the standards and regulations you’ve worked with, like ISO 13485 or IEC 62304. This will help us understand your expertise in the field.
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. We can’t wait to see what you bring to the table!
How to prepare for a job interview at SciPro
✨Know Your Regulations
Make sure you brush up on the key regulations and standards relevant to SaMD and AI technologies, like ISO 13485 and IEC 62304. Being able to discuss these in detail will show that you’re not just familiar with them, but that you can apply them effectively.
✨Showcase Your Cross-Functional Experience
Since this role involves working closely with various teams, be ready to share examples of how you've collaborated with Quality, Engineering, or Clinical Operations in the past. Highlighting your teamwork skills will demonstrate that you can thrive in a cross-functional environment.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or compliance issues. Think through some scenarios beforehand and prepare structured responses that showcase your problem-solving skills and regulatory knowledge.
✨Stay Updated on Industry Trends
Regulatory landscapes are always changing, especially in the tech space. Make sure you’re aware of the latest developments in AI and medical device regulations. Bringing up recent news or changes during your interview can show your passion and commitment to staying informed.
