At a Glance
- Tasks: Provide quality consultancy for medical devices and ensure compliance with regulations.
- Company: Join LFH, a leading medical device consultancy with a dynamic team.
- Benefits: Competitive salary up to £50k, life insurance, and professional development opportunities.
- Other info: Enjoy hybrid working with remote flexibility and occasional travel.
- Why this job: Make a real impact in the medical technology field while enhancing your skills.
- Qualifications: 2+ years in quality assurance within medical devices; knowledge of ISO 13485 is a plus.
The predicted salary is between 40000 - 50000 £ per year.
Are you an experienced quality assurance professional looking for a new challenge? LFH is a top medical device consultancy company that is seeking a permanent Quality Assurance Consultant.
Competitive Salary and compensation package:
- A salary of up to £50k pro rata depending on experience
- Company based bonus scheme
- Life Insurance
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.
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 quality 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
- UK Responsible Person services
To provide Medical Device and IVD Quality consultancy for LFH Regulatory and its associated clients. Fully support LFH Regulatory clients in ensuring required product portfolio are compliant with all regional regulations.
Implement and Maintain LFH Regulatory clients Quality Management System (QMS) in order to ensure compliance to all relevant regulatory and quality requirements.
Key Responsibilities:
- 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
- Work within LFH Regulatory’s eQMS, including help with implementation, improvements and maintenance
- 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
- Attend exhibitions, conferences and network events
Qualifications:
- Scientific, Engineering or Medical background with quality experience within the medical devices/IVD sector (ideally 2 or more years’ experience)
- Substantial experience in the implementation and maintenance of paper based quality management systems and electronic quality management systems
- Comprehensive understanding and Implementation of ISO 13485 and/or FDA 21 CFR Part 820 into quality management systems from inception and/or to upgrade existing systems
- Experience with electronic quality management systems
Employee Benefits Pensions Consultant - Hybrid Working in Huddersfield employer: LFH Regulatory Limited
At LFH Regulatory, we pride ourselves on being a leading medical device consultancy that offers a dynamic and supportive work environment. Our hybrid working model allows for flexibility while you engage in meaningful projects that enhance your professional growth in the medical device sector. With competitive salaries, a company bonus scheme, and opportunities to collaborate with cross-functional teams, you'll find a rewarding career path that not only challenges you but also contributes to the advancement of medical technology.
