Regulatory Consultant – Electronic Medical Devices (IEC 60601 Focus)
Regulatory Consultant – Electronic Medical Devices (IEC 60601 Focus)

Regulatory Consultant – Electronic Medical Devices (IEC 60601 Focus)

Nottingham Full-Time 60000 - 70000 £ / year (est.) Home office possible
L

At a Glance

  • 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)
  • 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.

Interested? Indo Search is representing IMed on an exclusive basis. Get in touch with Josh Craven at josh@indoprofessionals.co.uk or 07929 235128.

Regulatory Consultant – Electronic Medical Devices (IEC 60601 Focus) employer: LinkedIn

At IMed Consultancy, we pride ourselves on being an excellent employer that offers a fully remote working environment, allowing you to balance your professional and personal life while making a real impact in the MedTech industry. Our collaborative culture fosters strong relationships among a tight-knit team of experts, providing ample opportunities for professional growth and development through varied, high-impact projects. Join us to work on innovative solutions in regulatory affairs, all while enjoying the freedom and flexibility that comes with remote work in the UK or Ireland.
L

Contact Detail:

LinkedIn Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Regulatory Consultant – Electronic Medical Devices (IEC 60601 Focus)

Tip Number 1

Familiarise yourself with the latest updates on IEC 60601 and other relevant regulations. This will not only enhance your knowledge but also demonstrate your commitment to staying current in the field during any discussions.

Tip Number 2

Network with professionals in the MedTech industry, especially those who have experience with regulatory affairs. Engaging in conversations can provide insights into the role and may even lead to referrals.

Tip Number 3

Prepare to discuss specific examples from your past experiences where you successfully navigated regulatory challenges. This will showcase your problem-solving skills and practical knowledge during interviews.

Tip Number 4

Research IMed Consultancy thoroughly. Understanding their projects and values will help you tailor your approach and show genuine interest in becoming part of their team.

We think you need these skills to ace Regulatory Consultant – Electronic Medical Devices (IEC 60601 Focus)

Regulatory Affairs Expertise
Knowledge of IEC 60601 Standards
Experience with EU MDR and US FDA Submissions
Technical Documentation Review
Risk Management Skills
Clinical Evaluation Planning
Post-Market Compliance Knowledge
Global Market Access Strategy
Strong Communication Skills
Problem-Solving Skills
Ability to Work with Technical Teams
Stakeholder Engagement
Commercial Awareness
Adaptability in a Fast-Paced Environment

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights your regulatory experience specifically with electronic medical devices. Emphasise your knowledge of IEC 60601 and any relevant projects you've worked on that align with the job description.

Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the regulatory landscape for medical devices. Mention specific experiences where you successfully guided clients through FDA or EU MDR submissions, demonstrating your problem-solving skills.

Highlight Relevant Skills: In your application, clearly outline your skills related to risk management, usability, and clinical evaluation planning. These are crucial for the role and should be evident in your written materials.

Showcase Your Collaborative Spirit: Since the role involves working closely with clients and technical teams, include examples in your application that demonstrate your ability to collaborate effectively and build trusted relationships in a consultancy setting.

How to prepare for a job interview at LinkedIn

Know Your Regulations

Make sure you have a solid understanding of the EU MDR and US 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.

Regulatory Consultant – Electronic Medical Devices (IEC 60601 Focus)
LinkedIn
L
  • Regulatory Consultant – Electronic Medical Devices (IEC 60601 Focus)

    Nottingham
    Full-Time
    60000 - 70000 £ / year (est.)

    Application deadline: 2027-07-05

  • L

    LinkedIn

Similar positions in other companies
UK’s top job board for Gen Z
discover-jobs-cta
Discover now
>