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- Tasks: Manage client projects in regulatory affairs and quality assurance for medical devices.
- Company: Join LFH, a leading medical device consultancy with a dynamic team.
- Benefits: Enjoy a competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact in the medical technology field while enhancing your skills.
- Qualifications: Experience in regulatory affairs, quality management systems, and strong problem-solving skills.
- Other info: Fully remote role with occasional travel and exciting career advancement opportunities.
The predicted salary is between 42000 - 66000 £ per year.
Are you an experienced regulatory affairs and/or quality assurance 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 & Quality Assurance 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 £55k pro rata depending on experience
- Company based bonus scheme
- Life Insurance
- Health benefits
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 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. 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
- UK Responsible Person services
The Role Description:
Client facing responsibilities, including, but not limited to:
- Managing client projects
- Attending client meetings both remote and onsite as needed
- Implementing full and partial quality management systems that align with UK, EU, and US requirements/ISO 13485/21 CFR
- Maintaining client quality management systems and providing QMS support to clients
- Conducting gap assessments and auditing quality management systems
- Providing support to clients pre, during and post audit
- Creating, maintaining and conducting gap assessments on technical file documentation for clients
- Registering devices with regulatory authorities
- Liaising with notified/approved bodies and competent authorities
LFH responsibilities, including, but not limited to:
- Attending and participating in team meetings both remote and face to face
- Creating blog content for LinkedIn/Website and any other form of social media where required
- Creating, updating, and maintaining internal LFH Regulatory business processes and document employee training records
- Representing the business at exhibitions, conferences, and networking events as required
What are the requirements?
Essential:
- Must be based in the UK
- Willingness to learn and grow
- Problem-solving skills
- Knowledge of medical device regulations and standards, including EU MDR, IVDR, and ISO 13485
- Experience with device development, quality management systems, audits, technical documentation, risk management, and clinical requirements
- Understanding of recalls and adverse event management, product registration, and UK Responsible Person requirements
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
- Attention to detail and strong analytical skills
- Bachelor's degree or higher in a related field
Desired:
- US FDA experience
- Experience with Software as a Medical Device (SaMD)
- Relevant certifications or qualifications in regulatory affairs
Apply now and become a part of this exciting journey!
Regulatory Affairs & Quality Assurance Consultant in Leeds employer: LFH Regulatory Limited
Contact Detail:
LFH Regulatory Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs & Quality Assurance Consultant in Leeds
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs and quality assurance field. Attend industry events, webinars, or even local meet-ups. You never know who might have the inside scoop on job openings or can refer you directly to hiring managers.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Understand their approach to medical device regulation and think about how your skills align with their needs. This will help you stand out and show that you're genuinely interested in joining their team.
✨Tip Number 3
Practice your pitch! Be ready to explain your experience and how it relates to the role of a Regulatory Affairs & Quality Assurance Consultant. Highlight specific projects you've worked on and the impact you've made. Confidence is key!
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to engage directly with us. So, go ahead and submit your application today!
We think you need these skills to ace Regulatory Affairs & Quality Assurance Consultant in Leeds
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Regulatory Affairs & Quality Assurance Consultant. Highlight your relevant experience and skills that match the job description, especially in medical device regulations and quality management systems.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background makes you a perfect fit. Don’t forget to mention your eagerness to learn and grow with us at LFH.
Showcase Your Problem-Solving Skills: In your application, give examples of how you've tackled challenges in previous roles. We love candidates who can think on their feet and find solutions, so don’t hold back on sharing your success stories!
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It’s the best way to ensure your application gets into the right hands and shows your enthusiasm for joining our team!
How to prepare for a job interview at LFH Regulatory Limited
✨Know Your Regulations
Brush up on the latest medical device regulations, especially EU MDR, IVDR, and ISO 13485. Being able to discuss these confidently will show your expertise and readiness for the role.
✨Showcase Problem-Solving Skills
Prepare examples of how you've tackled challenges in previous roles. Highlight your ability to anticipate issues and drive consensus, as this is crucial for the Regulatory Affairs & Quality Assurance Consultant position.
✨Demonstrate Team Spirit
Since collaboration is key in this role, be ready to share experiences where you worked effectively within a team. Emphasise your willingness to learn and grow alongside your colleagues.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s projects and future growth. This not only shows your interest but also helps you gauge if the company aligns with your career aspirations.