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- Tasks: Lead regulatory strategies for innovative SaMD and AI products while ensuring compliance.
- Company: IMED Consultancy specializes in regulatory expertise for MedTech, fostering innovation and collaboration.
- Benefits: Enjoy a fully remote role with career growth opportunities and a supportive team environment.
- Why this job: Work on groundbreaking projects and make an impact in the rapidly evolving digital health field.
- Qualifications: Expertise in regulatory affairs, especially SaMD/AI, with strong communication and problem-solving skills.
- Other info: Ideal for experienced professionals seeking diverse projects and a flexible work-life balance.
The predicted salary is between 36000 - 60000 £ per year.
Regulatory Strategy Lead / Senior Consultant – SaMD/AI Focus
Location: Fully Remote (Applicants must be residing in UK or Ireland and have right to work)
Imagine starting your day from the comfort of your home office, fully remote yet fully connected. You log into a virtual meeting with a dynamic start-up, eager to bring their innovative SaMD product to market.
Later, you’re reviewing technical documentation for an SME preparing their AI-powered diagnostic tool for a critical 510(k) submission. Your engineering background enables you to guide their team through early-stage design considerations, ensuring their product is not only compliant but also robust and market-ready.
Your afternoon might involve advising another client on post-market surveillance strategies, leveraging your knowledge of clinical evaluation and vigilance to ensure continued global market access.
This role is ideal for experienced Regulatory Specialists, Managers, or Heads/Directors seeking a permanent position where they can apply their technical expertise and regulatory acumen. You’ll work with a variety of innovative SaMD and digital health companies, guiding regulatory strategies across projects at various stages of development.
What makes this role stand out?
- Diverse Projects: Engage with cutting-edge technologies and guide organisations through complex regulatory pathways.
- Collaborative Team: Work with a supportive team of 11 experts passionate about MedTech innovation.
- Career Growth: Join a consultancy with a strong track record of training and promoting from within.
- Flexibility: Enjoy the benefits of a fully remote position.
Typical responsibilities:
- Prepare technical documentation and design dossiers.
- Lead regulatory submissions, including EUMDR, EU IVDR, US FDA 510(k)s, PMAs, IDEs, and global approvals.
- Solve regulatory challenges on classification, technical files, and validation processes.
- Advise on or conduct design and product risk management activities.
- Prepare, review, or update Clinical Evaluation Reports (CERs).
- Support post-market surveillance and ensure compliance with global regulatory requirements.
What we’re looking for:
- Expertise in regulatory affairs with a focus on SaMD/AI.
- Proven experience navigating MDR and FDA pathways.
- A background in engineering or the ability to support early-stage product development.
- Exceptional communication skills with a client-focused approach.
- A solutions-oriented, commercially minded mindset.
About the Company
Founded in 2012, IMED Consultancy has built a strong reputation for delivering regulatory expertise to a loyal and diverse client base. Led by a hands-on CEO passionate about MedTech innovation, the company values knowledge-sharing and collaboration, with a team dedicated to driving client success.
Why Join?
- Work on groundbreaking projects at the forefront of digital health.
- Collaborate with innovative start-ups and growing SMEs.
- Enjoy a flexible, fully remote role.
- Benefit from career growth opportunities in a company that promotes from within.
- Be part of a supportive, collaborative team environment.
If you’re looking for variety, flexibility, and the chance to make an impact in a rapidly evolving field, we’d love to hear from you.
Regulatory Strategy Lead / Senior Consultant - SaMD/AI employer: Indo Search
Contact Detail:
Indo Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Strategy Lead / Senior Consultant - SaMD/AI
✨Tip Number 1
Make sure to highlight your experience with regulatory submissions, especially in relation to SaMD and AI. Familiarize yourself with the specific requirements of EUMDR, EU IVDR, and US FDA pathways, as this knowledge will be crucial during discussions.
✨Tip Number 2
Network with professionals in the MedTech and regulatory affairs space. Engaging with industry groups or attending relevant webinars can help you connect with potential colleagues and gain insights into current trends and challenges.
✨Tip Number 3
Prepare to discuss your engineering background and how it relates to regulatory strategy. Be ready to share examples of how you've guided teams through design considerations and compliance challenges in previous roles.
✨Tip Number 4
Showcase your client-focused approach and exceptional communication skills. Think of specific instances where you've successfully collaborated with clients to solve regulatory challenges, as this will demonstrate your value to the team.
We think you need these skills to ace Regulatory Strategy Lead / Senior Consultant - SaMD/AI
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your expertise in regulatory affairs, particularly in SaMD and AI. Emphasize your experience with MDR and FDA pathways, as well as any engineering background that supports product development.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for MedTech innovation and your client-focused approach. Mention specific projects or experiences that demonstrate your ability to navigate complex regulatory challenges.
Highlight Relevant Skills: In your application, clearly outline your exceptional communication skills and solutions-oriented mindset. Provide examples of how you've successfully advised clients or led regulatory submissions in the past.
Showcase Your Collaborative Spirit: Since the role involves working with a supportive team, mention any previous experiences where you collaborated effectively with others. Highlight your ability to work in a remote environment while staying connected with your team.
How to prepare for a job interview at Indo Search
✨Showcase Your Regulatory Expertise
Be prepared to discuss your experience with regulatory submissions, particularly in relation to SaMD and AI. Highlight specific projects where you successfully navigated MDR and FDA pathways, as this will demonstrate your capability to handle the responsibilities of the role.
✨Demonstrate Technical Knowledge
Since the role requires an engineering background, be ready to explain how your technical skills have contributed to product development. Discuss any relevant design considerations or risk management activities you've been involved in, showcasing your ability to guide teams through complex processes.
✨Emphasize Communication Skills
Exceptional communication is key in this role. Prepare examples of how you've effectively communicated with clients or team members in past projects. This could include advising on regulatory challenges or collaborating on technical documentation, which will illustrate your client-focused approach.
✨Express Your Solutions-Oriented Mindset
The company values a solutions-oriented and commercially minded approach. Be ready to share instances where you've identified regulatory challenges and proposed effective solutions. This will show that you can think critically and contribute positively to the team's objectives.
