Senior Regulatory Affairs Manager – AI SaMD (UK/EU/US) in London

Senior Regulatory Affairs Manager – AI SaMD (UK/EU/US) in London

London Full-Time 60000 - 80000 € / year (est.) No home office possible
SciPro

At a Glance

  • Tasks: Lead regulatory strategy for AI medical software and oversee compliance.
  • Company: Join a forward-thinking company dedicated to innovative healthcare solutions.
  • Benefits: Attractive salary, flexible working options, and opportunities for professional growth.
  • Other info: Be part of a dynamic team shaping the future of medical technology.
  • Why this job: Make a difference in healthcare by ensuring cutting-edge technologies meet vital standards.
  • Qualifications: Experience in regulatory affairs for SaMD and strong communication skills.

The predicted salary is between 60000 - 80000 € per year.

SciPro is looking for a Senior Regulatory Affairs Manager to lead regulatory strategy and compliance for AI-enabled medical software in the UK. This role involves overseeing regulatory submissions and ensuring adherence to standards like ISO 13485 and IEC 62304.

The ideal candidate will have:

  • Experience in regulatory affairs for SaMD
  • Strong knowledge of global regulations
  • Excellent communication skills

Join us in ensuring that innovative technologies meet essential regulatory and quality standards.

Senior Regulatory Affairs Manager – AI SaMD (UK/EU/US) in London employer: SciPro

At SciPro, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the rapidly evolving field of AI-enabled medical software. Our commitment to employee growth is reflected in our comprehensive training programmes and opportunities for advancement, ensuring that you can thrive in your career while making a meaningful impact on healthcare standards. Located in the heart of the UK, we provide a supportive environment where your expertise in regulatory affairs will be valued and recognised.

SciPro

Contact Detail:

SciPro Recruiting Team

StudySmarter Expert Advice🀫

We think this is how you could land Senior Regulatory Affairs Manager – AI SaMD (UK/EU/US) in London

✨Tip Number 1

Network like a pro! Reach out to professionals in the regulatory affairs field, especially those with experience in AI SaMD. Attend industry events or webinars to make connections and learn about potential job openings.

✨Tip Number 2

Prepare for interviews by brushing up on your knowledge of ISO 13485 and IEC 62304. We want you to be able to discuss how these standards apply to AI-enabled medical software confidently.

✨Tip Number 3

Showcase your communication skills! During interviews, be clear and concise when discussing your past experiences in regulatory affairs. We need to see how you can convey complex information effectively.

✨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 take that extra step to connect with us directly.

We think you need these skills to ace Senior Regulatory Affairs Manager – AI SaMD (UK/EU/US) in London

Regulatory Strategy
Regulatory Compliance
ISO 13485
IEC 62304
Experience in Regulatory Affairs for SaMD
Knowledge of Global Regulations
Communication Skills

Some tips for your application 🫑

Tailor Your CV:Make sure your CV highlights your experience in regulatory affairs, especially for AI-enabled medical software. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects and achievements!

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 the AI SaMD space. We love seeing candidates who can communicate their enthusiasm and understanding of the industry.

Showcase Your Knowledge of Standards:Since this role involves adherence to standards like ISO 13485 and IEC 62304, make sure to mention your familiarity with these regulations. We appreciate candidates who can demonstrate their expertise and how it applies to our work.

Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!

How to prepare for a job interview at SciPro

✨Know Your Regulations

Make sure you brush up on the key regulations like ISO 13485 and IEC 62304. Being able to discuss these standards confidently will show that you’re not just familiar with them, but that you can apply them in real-world scenarios.

✨Showcase Your Experience

Prepare specific examples from your past roles where you successfully navigated regulatory challenges for AI-enabled medical software. This will help demonstrate your expertise and how you can bring value to the team.

✨Communicate Clearly

Since excellent communication skills are a must, practice articulating complex regulatory concepts in simple terms. This will not only impress your interviewers but also reflect your ability to work cross-functionally with different teams.

✨Stay Updated on Trends

Familiarise yourself with the latest trends and developments in regulatory affairs for SaMD. Being knowledgeable about current events shows your passion for the field and your commitment to staying ahead of the curve.