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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 remotely in a stimulating environment with opportunities for professional growth.
- Qualifications: Degree or relevant experience in medical devices/IVD; 2+ years in regulatory affairs preferred.
- Other info: Fully remote position with occasional travel; collaborate with cross-functional teams.
The predicted salary is between 42000 - 66000 £ per year.
Job Description
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.
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 Regulatory Affairs & Clinical Consultant
✨Tip Number 1
Make sure to network with professionals in the regulatory affairs and clinical fields. Attend industry conferences, webinars, or local meetups to connect with others who may have insights or leads on job openings at LFH.
✨Tip Number 2
Stay updated on the latest regulations and guidelines in the medical device sector. Familiarize yourself with ISO 13485 and FDA regulations, as this knowledge will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 3
Prepare to discuss specific projects you've worked on that relate to regulatory strategies and clinical evaluations. Highlight your experience with technical documentation and any successful audits you've participated in to showcase your expertise.
✨Tip Number 4
Research LFH's recent projects and clients to understand their focus areas. Tailoring your conversation during interviews to reflect your knowledge of their work can set you apart from other candidates.
We think you need these skills to ace Regulatory Affairs & Clinical Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory affairs and clinical roles. Focus on specific projects you've worked on, especially those related to medical devices and IVDs.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention your understanding of the regulatory landscape and how your background aligns with the responsibilities outlined in the job description.
Highlight Relevant Skills: In your application, emphasize key skills such as project management, attention to detail, and your ability to liaise with clients and regulatory bodies. These are crucial for the role of Regulatory Affairs & Clinical Consultant.
Showcase Continuous Learning: Mention any recent training or certifications related to regulatory affairs or medical device regulations. This demonstrates your commitment to professional growth and staying updated in the field.
How to prepare for a job interview at LFH Regulatory Limited
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of regulatory frameworks, especially ISO 13485 and FDA regulations. Be prepared to discuss specific experiences where you successfully navigated these regulations in past roles.
✨Demonstrate Client Management Skills
Since the role involves client-facing responsibilities, share examples of how you've effectively managed client relationships. Discuss any challenges you faced and how you overcame them to build trust and deliver results.
✨Prepare for Technical Questions
Expect questions related to technical documentation and clinical evaluations. Brush up on your knowledge of Performance Evaluation and Clinical Evaluation documentation, and be ready to explain your process for compiling and reviewing these documents.
✨Emphasize Team Collaboration
The job requires working within cross-functional teams. Share instances where you collaborated with others to achieve a common goal, highlighting your interpersonal skills and ability to communicate effectively.
