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For Companies At a Glance
- Tasks: Provide consultancy on medical devices and IVD, ensuring compliance with regulations.
- Company: Join LFH, a leading medical device consultancy known for innovation and growth.
- Benefits: Enjoy a competitive salary, health benefits, flexible working, and professional development opportunities.
- Why this job: Be part of a dynamic team making a real impact in medical technology while enhancing your skills.
- Qualifications: Degree or relevant experience in science, engineering, or medicine; 2+ years in medical devices preferred.
- Other info: This role is fully remote with occasional travel required.
The predicted salary is between 43200 - 72000 £ per year.
Are you an experienced clinical professional looking for a new challenge? If so, we have just the opportunity for you! LFH is a top medical device consultancy company that is seeking a permanent Clinical Consultant. We are open to full time as well as part time applicants between 3 to 5 days.
What benefits will you get?
- Competitive Salary and compensation package: A salary of up to £60k pro rata depending on experience.
- Company based bonus scheme.
- Health benefits including life insurance and critical illness.
- Flexible working.
Professional growth and development: You’ll have the opportunity to work on a diverse range of projects, from writing and editing regulatory documents to providing oversight for outsourced deliverables to our clients. You will be able to enhance your skills and broaden your knowledge in the field of medical device regulation. As the business is rapidly growing year on year, there are many exciting opportunities ahead!
Stimulating work environment: Join a team at the forefront of medical device & IVD regulation, where every day brings new challenges and opportunities to make a difference and learn new things. Collaborate with cross-functional teams and contribute to the development of crucial clinical documents that impact the advancement of medical technology.
About LFH Regulatory: We work with varying companies that have diverse ranges of technologies which offers a stimulating work environment, and ample opportunities for professional growth and development. This job is fully remote but with occasional travel.
Responsibilities:
- To provide Medical Device and IVD Clinical consultancy for LFH Regulatory and its associated clients.
- Fully support LFH Regulatory clients in ensuring required product portfolio are compliant with all regional regulations.
- Maintain LFH Regulatory clients Clinical Documentation to ensure compliance to all relevant requirements.
- Conduct Technical / Medical Writing.
- Ability to conduct literature reviews, assess clinical data, and collate findings into structured reports.
- Ability to critically evaluate scientific literature and clinical data.
- Skilled in identifying relevant clinical endpoints, performance claims, and safety data for regulatory submissions.
- Create, maintain and conduct gap assessments on documentation for clients, including but not limited to: Clinical Evaluation, Performance Evaluation, Biological Evaluation, Other clinical or performance documentation.
- Feedback clinical/performance inputs into Technical Files, Risk Management and documentation.
Qualifications:
- Degree educated or relevant industry experience.
- Scientific, Engineering or Medical background with clinical and regulatory experience within the medical devices/IVD sector (ideally 2 or more years’ experience).
- Experience in the compilation and review of Performance Evaluation/ Clinical Evaluation documentation and EU/UK technical documentation for CE/UKCA marking. US experience is desirable.
- Assess all necessary and specific medical device regulatory obligations and to be able to advise staff and clients accordingly.
- An understanding of ISO 13485 and/or FDA 21 CFR Part 820.
- Must work well within a team with good interpersonal and communication skills.
- Excellent attention to detail is essential.
- Suitable general IT skills.
To apply you must be based in the UK. Remote working with occasional travel as and when needed to meet business need.
Contact Detail:
LFH Regulatory Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Consultant
✨Tip Number 1
Network with professionals in the medical device and IVD sectors. Attend industry conferences, webinars, or local meetups to connect with potential colleagues and learn about the latest trends. This can help you gain insights into the role and make valuable connections that could lead to a referral.
✨Tip Number 2
Familiarise yourself with the specific regulations and standards relevant to the role, such as ISO 13485 and FDA guidelines. Being well-versed in these areas will not only boost your confidence but also demonstrate your commitment and expertise during interviews.
✨Tip Number 3
Prepare for the interview by practising common clinical consultancy scenarios. Think about how you would handle specific challenges related to regulatory compliance or technical writing. This will help you articulate your problem-solving skills and experience effectively.
✨Tip Number 4
Showcase your ability to work collaboratively by highlighting past experiences where you successfully worked within cross-functional teams. Emphasising your interpersonal skills will be crucial, as this role involves collaboration with various stakeholders.
We think you need these skills to ace Clinical Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant clinical and regulatory experience in the medical devices or IVD sector. Emphasise any specific projects or roles that align with the responsibilities mentioned in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention your understanding of ISO 13485 and FDA regulations, and how your skills can contribute to LFH's mission in medical device consultancy.
Highlight Relevant Experience: In your application, focus on your experience with clinical evaluations, performance evaluations, and technical documentation. Provide examples of how you've successfully navigated regulatory requirements in previous roles.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. Attention to detail is crucial in this field, so ensure your application reflects that quality.
How to prepare for a job interview at LFH Regulatory Limited
✨Showcase Your Clinical Expertise
Make sure to highlight your clinical and regulatory experience during the interview. Be prepared to discuss specific projects you've worked on, especially those related to medical devices and IVDs, as this will demonstrate your suitability for the role.
✨Understand the Company’s Services
Familiarise yourself with LFH Regulatory's services, such as CE/UKCA marking certification and quality management systems. This knowledge will allow you to ask informed questions and show your genuine interest in the company’s operations.
✨Prepare for Technical Questions
Expect technical questions related to clinical evaluations, performance claims, and regulatory submissions. Brush up on relevant regulations like ISO 13485 and FDA guidelines to confidently answer these queries.
✨Demonstrate Team Collaboration Skills
Since the role involves working with cross-functional teams, be ready to provide examples of how you've successfully collaborated in the past. Highlight your interpersonal skills and ability to communicate effectively within a team setting.
