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- Tasks: Join us as a Technical Writer, crafting essential clinical documents and ensuring regulatory compliance.
- Company: LFH is a leading medical device consultancy, driving innovation in healthcare technology.
- Benefits: Enjoy a competitive salary, flexible working, health benefits, and opportunities for professional growth.
- Why this job: Be part of a dynamic team making a real impact in medical technology with exciting career prospects.
- 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; perfect for those seeking flexibility.
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 Technical Writer / 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.
Technical Writer employer: LFH Regulatory Limited
Contact Detail:
LFH Regulatory Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Technical Writer
✨Tip Number 1
Familiarise yourself with the latest regulations and standards in the medical device industry, particularly ISO 13485 and FDA guidelines. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the medical device sector through platforms like LinkedIn or industry-specific forums. Engaging with others in the field can provide insights into the company culture at LFH and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your previous work related to clinical documentation and regulatory submissions. Highlighting your experience with Performance Evaluation and Clinical Evaluation documentation will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to work collaboratively by preparing examples of successful teamwork in past roles. Since this position involves cross-functional collaboration, demonstrating your interpersonal skills will be crucial in making a strong impression.
We think you need these skills to ace Technical Writer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in technical writing and clinical consultancy. Emphasise any specific projects or roles that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for medical devices and regulatory compliance. Mention your understanding of ISO 13485 and FDA regulations, and how your background makes you a perfect fit for LFH.
Highlight Relevant Skills: In your application, clearly outline your skills in conducting literature reviews, assessing clinical data, and creating structured reports. These are crucial for the role and should be front and centre in your application.
Proofread Your Application: Before submitting, thoroughly proofread your CV and cover letter. Attention to detail is essential for this role, so ensure there are no typos or grammatical errors that could detract from your professionalism.
How to prepare for a job interview at LFH Regulatory Limited
✨Showcase Your Technical Writing Skills
Prepare samples of your previous technical writing work, especially those related to medical devices or clinical documentation. Be ready to discuss your writing process and how you ensure clarity and compliance in your documents.
✨Understand Regulatory Requirements
Familiarise yourself with the key regulations and standards relevant to medical devices, such as ISO 13485 and FDA guidelines. Demonstrating your knowledge of these regulations will show that you are well-prepared for the role.
✨Highlight Your Collaborative Experience
Since the role involves working with cross-functional teams, be prepared to share examples of how you've successfully collaborated with others in past projects. Emphasise your communication skills and ability to work within a team.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's projects, culture, and growth opportunities. This not only shows your interest in the position but also helps you assess if the company aligns with your career goals.
