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For Companies At a Glance
- Tasks: Manage client projects and create regulatory strategies for medical devices.
- Company: Join LFH, a leading medical device consultancy with diverse technologies.
- Benefits: Enjoy a competitive salary up to £55k pro rata and a bonus scheme.
- Why this job: Work in a stimulating environment with opportunities for professional growth and remote work.
- Qualifications: Degree or relevant experience in scientific, engineering, or medical fields; 2+ years in regulatory affairs.
- Other info: Fully remote position with occasional travel; collaborate with cross-functional teams.
The predicted salary is between 42000 - 66000 £ per year.
Are you an experienced regulatory affairs and/or 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 Regulatory Affairs & 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: We understand the value of your skills and expertise. We offer?
- A salary of up to £55k pro rata depending on experience
- Company based bonus scheme
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. Not only this, as the business is rapidly growing year on year, there is no limitations on where you can go in the company with 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 regulatory 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. If you like working from home, know that this job is fully remote but with occasional travel.
Our services include device development and CE/UKCA marking certification, global regulatory strategies, US FDA, quality management system creation and ongoing support to ISO 13485, internal/supplier audits, remediating audit findings, technical documentation, risk management activities to ISO 14971, clinical requirements, recalls and adverse event management, product registration, and UK Responsible Person services.
The Role Description
Client facing responsibilities, including, but not limited to:
The Regulatory Affairs & Quality Assurance Consultant will be responsible for managing client projects that includes:
-Onboarding new clients and exploring new business opportunities during client meetings
-Attending client meetings both remote and onsite as and when needed
-Creating regulatory strategies for global markets including classification of medical devices and IVDs,
-Creating, maintaining, and conducting gap assessments on technical file documentation for clients, including, but not limited to:
- Risk management
- Post-market surveillance
- Essential Requirements Checklist (ERCs) and General Safety and Performance Requirements (GSPRs),
- Clinical Evaluation
- Biological Evaluation
- Usability Engineering
- Instructions for use and labels
- Applied standards
-Registering devices with regulatory authorities,
-Reviewing and preparing UK responsible person documentation,
-Liaising with Notified/Approved Bodies and Competent Authorities
-Providing support to clients pre, during and post audit, including audit preparation, attending audits, and assisting with non-conformities.
What are the requirements?
-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),
-Substantial 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.
-Commercial awareness and appreciation
-Excellent attention to detail is essential.
LFH Regulatory Limited | Regulatory Affairs & Clinical Consultant employer: LFH Regulatory Limited
Contact Detail:
LFH Regulatory Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land LFH Regulatory Limited | Regulatory Affairs & Clinical Consultant
✨Tip Number 1
Make sure to highlight your relevant experience in regulatory affairs and clinical evaluation during networking opportunities. Attend industry conferences or webinars where you can meet professionals from LFH Regulatory and discuss your background and interest in the role.
✨Tip Number 2
Familiarize yourself with the latest trends and regulations in the medical device sector, especially regarding CE/UKCA marking and FDA requirements. This knowledge will not only help you stand out but also demonstrate your commitment to staying updated in this fast-paced field.
✨Tip Number 3
Engage with LFH Regulatory on social media platforms like LinkedIn. Share relevant articles or insights related to regulatory affairs and clinical practices, which can help you get noticed by the hiring team and show your passion for the industry.
✨Tip Number 4
Prepare to discuss specific projects you've worked on that relate to the responsibilities outlined in the job description. Being able to articulate your hands-on experience with technical documentation and client management will give you a significant edge during interviews.
We think you need these skills to ace LFH Regulatory Limited | Regulatory Affairs & Clinical Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure to customize your CV to highlight your relevant experience in regulatory affairs and clinical roles. Emphasize your background in medical devices and any specific projects that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the medical device industry. Mention specific experiences that demonstrate your ability to manage client projects and create regulatory strategies.
Highlight Relevant Skills: In your application, clearly outline your skills related to ISO 13485, FDA regulations, and your experience with technical documentation. This will show that you are well-versed in the requirements of the role.
Showcase Professional Growth: Discuss your commitment to professional development in your application. Mention any relevant certifications, training, or courses you have completed that enhance your qualifications for this position.
How to prepare for a job interview at LFH Regulatory Limited
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of medical device regulations, especially ISO 13485 and FDA 21 CFR Part 820. Be prepared to discuss specific experiences where you successfully navigated regulatory challenges.
✨Demonstrate Client Management Skills
Since the role involves client-facing responsibilities, share examples of how you've effectively managed client relationships in the past. Discuss any strategies you've used to onboard new clients or explore business opportunities.
✨Prepare for Technical Questions
Expect questions related to technical file documentation and clinical evaluations. Brush up on your knowledge of risk management, post-market surveillance, and essential requirements to confidently answer these queries.
✨Emphasize Team Collaboration
The job requires working with cross-functional teams, so be ready to talk about your teamwork experiences. Highlight instances where you contributed to a project’s success through collaboration and effective communication.
