Quality Regulatory Consultant
3 weeks ago
Are you an experienced regulatory affairs and quality assurance professional looking for a new challenge? LFH is a top medical device consultancy company that is seeking a Regulatory Affairs & Quality Assurance Consultant for fixed term contract of 12 months with possible extension to join our dynamic team. 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 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,
Risk management
Essential Requirements Checklist (ERCs) and General Safety and Performance Requirements (GSPRs),
Registering devices with regulatory authorities,
Providing support to clients pre, during and post audit, including audit preparation, attending audits, and assisting with non-conformities.
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
Attending exhibitions, conferences, and network events .
Minimum of 3-5 years of experience in regulatory affairs and/or quality assurance within the medical device/IVD industry
As a Senior Regulatory Consultant, you’ll need to be a proactive problem solver. Your ability to anticipate issues, drive project consensus, and find solutions will be crucial in this role
In-depth 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
Relevant certifications or qualifications in regulatory affairs
Bachelor's degree or higher in a related field.
Experience with Software as a Medical Device (SaMD)
Implementation of full and partial quality management systems by creating/writing procedures, controlled forms, and work instructions
Competitive Salary and compensation package: We offer a salary of up to £60k depending on experience.
Professional growth and development: As a Regulatory Affairs & Quality Assurance Consultant, 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 regulation, where every day brings new challenges and opportunities to make a difference. Collaborate with cross-functional teams and contribute to the development of crucial regulatory documents that impact the advancement of medical technology.
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