At a Glance
- Tasks: Manage client projects in regulatory affairs and quality assurance for medical devices.
- Company: Join LFH Regulatory, a leading medical device consultancy with a dynamic team.
- Benefits: Enjoy a competitive salary, health benefits, and opportunities for professional growth.
- Other info: Fully remote role with flexible hours and exciting career advancement opportunities.
- 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 required.
The predicted salary is between 48000 - 60000 £ per year.
Are you an experienced regulatory affairs and quality assurance professional looking for a new challenge? If so, we have just the opportunity for you. LFH Regulatory is a top medical device consultancy company that is seeking a fixed term contract Regulatory Affairs & Quality Assurance Consultant for 5 months with the possibility to extend or move to permanent. 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
- 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.
- 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.
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.
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:
- Attend client meetings both remote and onsite as needed
- Implement full and partial quality management systems, that align with UK, EU, and US requirements/ISO 13485/21 CFR, by creating/writing procedures, controlled forms, and work instructions
- Maintain client quality management systems and provide QMS support to clients
- Conduct gap assessments and audit quality management systems
- Provide support to clients pre, during and post audit, including audit preparation, attending audits and assisting with non-conformities
- Create, maintain and conduct gap assessments on technical file documentation for clients
- Register devices with regulatory authorities
- Liaise with notified/approved bodies and competent authorities
LFH responsibilities, including, but not limited to:
- Attend and participate in team meetings both remote and face to face
- Create blog content for LinkedIn/Website and any other form of social media where required
- Create, update, and maintain internal LFH Regulatory business processes and document employee training records
- Represent 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
- Excellent communication and interpersonal skills
- 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!
Quality Assurance & Regulatory Affairs Consultant (FTC 5 months) in Leeds employer: LFH Regulatory Limited
At LFH Regulatory, we pride ourselves on being a leading medical device consultancy that values innovation and excellence in quality assurance and regulatory affairs. Our collaborative work culture fosters professional growth, offering employees the chance to enhance their skills while contributing to impactful projects in the healthcare sector. Located in a vibrant area, we provide a supportive environment that encourages work-life balance and personal development, making us an exceptional employer for those seeking meaningful and rewarding careers.
