Medical Device Quality Lead
1 week ago
Are you a motivated Medical Device Quality Lead looking for a new challenge? We are seeking a talented professional with expertise in Quality & Regulatory affairs to join our team in London.
The ideal candidate will possess a robust background in quality management and be capable of collaborating across different teams. They will play a pivotal role in supporting the company throughout the entire product development and testing lifecycle, ensuring that the organization achieves its Quality and Business Objectives.
This role will offer you:
- The ability to implement and shape the quality department, with support and guidance from senior leadership.
- A creative and flexible working environment.
- Opportunities to advance and progress your career at any level.
You will be responsible for:
- Leading the creation of online training materials related to the design, development, and quality management of medical devices.
- Evaluating and authorizing project documentation as needed.
- Assisting in establishing regulatory pathways in partner Low- and Middle-Income Countries (LMICs) for collaborative projects.
- Serving as the primary contact for initial regulatory guidance to Accelerator projects.
- Coordinating with external quality/regulatory experts, overseeing contracts related to quality and regulatory tasks.
- Completing necessary training as required.
- Performing other duties appropriate to the position's grade as directed by the supervisor.
This role requires:
- A minimum educational attainment of a bachelor's degree (or equivalent) in a science or engineering field.
- Completed training in ISO 13485 Quality Management System (QMS) implementation or an equivalent program.
- Demonstrated experience in overseeing the successful delivery of outcomes, effectively engaging and directing diverse groups of suppliers, colleagues, and collaborators, and providing formal reports on the same.
- Familiarity with the UK Medical Device Regulation (MDR), 21CFR820, MDR, and regulatory requirements in the USA (fda).
We offer a competitive salary of £65,000 - £85,000 per annum, depending on experience.
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