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 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
✨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 will help you stand out during interviews and demonstrate your value to potential employers.
✨Tip Number 3
Practice your pitch! Be ready to discuss your experience with ISO standards and risk management processes. Tailor your responses to show how your skills align with the needs of the role and the company.
✨Tip Number 4
Apply through our website! We’ve got a streamlined application process that makes it easy for you to showcase your qualifications. Don’t miss out on the chance to join a team that values innovation in regulatory affairs.
We think you need these skills to ace Senior 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, 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 can also apply them in real-world scenarios.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've 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 this role involves working closely with various teams, be ready to discuss how you've effectively communicated and collaborated with different stakeholders in previous positions. Highlight any experiences where you facilitated discussions between technical and non-technical teams.
✨Stay Updated on Trends
Demonstrate your knowledge of current trends in AI and SaMD by discussing recent developments or changes in regulations. This shows that you’re proactive and genuinely interested in the field, which is a big plus for any employer.
