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- Tasks: Guide MedTech companies through regulatory challenges for electronic medical devices.
- Company: IMed Consultancy helps innovative MedTech firms navigate regulatory landscapes since 2012.
- Benefits: Enjoy a fully remote role with a competitive salary and real development opportunities.
- Why this job: Make a meaningful impact while working on diverse projects with a supportive team.
- Qualifications: Experience in regulatory affairs for electronic medical devices and knowledge of MDR and FDA pathways required.
- Other info: Join a collaborative team of 11 consultants with no red tape.
The predicted salary is between 60000 - 70000 £ per year.
Remote (UK or Ireland based) | Circa £60,000 – £70,000+ Applicants must have the right to work in the UK or Ireland and either already be residing there or have a clear, committed plan to relocate. This role requires in-depth experience in regulatory affairs within active (electronic) medical devices. Applicants with detailed experience in electronic medical device development seeking a higher salary will also be considered.
What if your next role offered both freedom and real impact? You start the day from home, coffee in hand, dialling into a call with a MedTech founder. Their product is a connected therapeutic device set to transform remote care, but they need help navigating the regulatory landscape. You listen, ask the right questions, and offer clear, practical guidance that keeps their innovation on track without losing pace. That afternoon, a different challenge: reviewing documentation for a scaling company preparing their first FDA submission. You’ve seen where this can go wrong, and you know how to steer it right. You spot the gaps, help tighten the strategy, and give the client the confidence they need. It’s varied, meaningful work — delivered with autonomy and backed by a team of experts. At IMed Consultancy, no two weeks look the same. You might be helping one client plan market entry into the US, supporting another with MDR strategy for a Class IIb platform, and advising a third on post-market obligations. The common thread? Trusted relationships and technically ambitious projects. You’ll join a tight-knit team of 11 consultants. Each brings something different, but everyone works collaboratively. There’s no red tape — just good people doing great work.
What You’ll Do
- Leading and supporting EU MDR and US FDA submissions
- Guiding clients on regulatory strategy across the full product lifecycle
- Building and reviewing technical documentation, from DHF to CERs
- Contributing to risk management, usability, and clinical evaluation planning
- Supporting post-market compliance and global market access strategy
- Acting as a trusted advisor to startups and scaling MedTech companies
What You’ll Bring
- Regulatory experience with active or electronic medical devices
- Strong understanding of MDR and FDA pathways
- Detailed knowledge of IEC 60601 and a desire to deepen that specialism
- Confidence working with technical teams and senior stakeholders
- A pragmatic, commercially minded approach to problem-solving
What You’ll Get
- £60,000 – £70,000+ basic salary (or equivalent in Euros for Ireland-based applicants)
- Applicants with in-depth experience of electronic medical device development seeking a higher salary will also be considered
- Fully remote role (UK or Ireland based)
- Varied, high-impact project work
- Real development opportunities — in consulting and beyond
- A supportive, expert team that shares your standards
About IMed Consultancy
IMed is a specialist RA/QA consultancy founded in 2012, known for helping innovative MedTech companies bring devices to market across the UK, EU, and US. From digital health to complex electro-mechanical systems, we simplify regulatory complexity and enable innovation.
Regulatory Consultant – Electronic Medical Devices (IEC 60601 Focus) employer: Indo Search
Contact Detail:
Indo Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Consultant – Electronic Medical Devices (IEC 60601 Focus)
✨Tip Number 1
Network with professionals in the MedTech industry, especially those who have experience with electronic medical devices. Attend relevant webinars or conferences to meet potential colleagues and learn about the latest trends in regulatory affairs.
✨Tip Number 2
Familiarise yourself with the specific requirements of IEC 60601 and how it applies to electronic medical devices. This knowledge will not only boost your confidence but also demonstrate your commitment to the role during discussions with potential employers.
✨Tip Number 3
Engage with online communities and forums focused on regulatory affairs in the MedTech sector. Sharing insights and asking questions can help you build relationships and gain valuable information that may set you apart from other candidates.
✨Tip Number 4
Consider reaching out directly to current employees at IMed Consultancy via LinkedIn. Express your interest in the Regulatory Consultant position and ask for insights about the company culture and expectations, which can help you tailor your approach.
We think you need these skills to ace Regulatory Consultant – Electronic Medical Devices (IEC 60601 Focus)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your regulatory experience specifically related to electronic medical devices. Emphasise your knowledge of IEC 60601 and any relevant projects you've worked on.
Craft a Compelling Cover Letter: In your cover letter, explain why you're passionate about regulatory affairs in the MedTech sector. Mention specific experiences that demonstrate your ability to guide clients through the regulatory landscape.
Showcase Relevant Skills: Clearly outline your understanding of EU MDR and US FDA pathways in your application. Include examples of how you've successfully navigated these processes in previous roles.
Highlight Collaborative Experience: Since the role involves working with technical teams and senior stakeholders, provide examples of past collaborations. Show how you’ve built trusted relationships and contributed to team success.
How to prepare for a job interview at Indo Search
✨Know Your Regulations
Make sure you have a solid understanding of the MDR and FDA pathways, as well as IEC 60601 standards. Be prepared to discuss how your experience aligns with these regulations and how you've successfully navigated them in past roles.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled complex regulatory challenges in the past. Highlight your pragmatic approach and how it has led to successful outcomes for clients or projects.
✨Demonstrate Collaborative Spirit
Since the role involves working closely with technical teams and stakeholders, be ready to share experiences where you've effectively collaborated with others. Emphasise your ability to build trusted relationships and work within a team.
✨Ask Insightful Questions
During the interview, ask questions that show your interest in the company's projects and their approach to regulatory consultancy. This not only demonstrates your enthusiasm but also helps you gauge if the company is the right fit for you.
