Axial3D Ltd is recruiting an experienced Quality & Regulatory Manager to provide quality management and regulatory affairs leadership across the business within a highly regulated medical device environment. Axial3D specialises in the delivery of 3D printing software and services to the healthcare sector, providing machine learning-based solutions that support the integration of 3D printing into the treatment pathway, driving improved surgical outcomes for patients.
The Role
Successful leadership of the Quality Management System (ISO:9001/13485) in line with relevant regulatory requirements and industry standards. Preparation and submission of required documents
Drive the internal compliance culture within the company and set the strategic quality objectives of the company ensuring that the right solutions are adopted by the company
Support in the preparation of technical documentation (including intellectual property submissions) as well as ethical and information governance policies to ensure successful delivery of the product
Manage the product lifecycle ensuring that appropriate controls are implemented pursuant to relevant regulatory requirements such as IEC 62304, ISO:27001 & ISO:13485
Drive the product development process ensuring that relevant requirements are addressed early in the product lifecycle and that claims are fully supported by our documentation
Lead in the development of Axial3D’s new regulatory processes such as 510K submissions.
Drive product research by putting in place robust processes and appropriate documentation for the collection of customer and product requirements
Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation
Provide Leadership to all staff on regulatory affairs and quality assurance ensuring that the company exceeds compliance requirements
Risk Management collaborate with R&D and Commercial Operations functions to identify and mitigate product risks to develop robust combination products and medical devices
Represent Company during audit functions associated with regulatory requirements
The Opportunity
Axial3D is a rapidly growing and award-winning start-up and its success is built on the desire, determination, and talent of its employees.
It’s a fun and growing team and axial3D offers the opportunity for your ideas to be implemented and to recognized and rewarded for your achievements. We are a diverse group of people committed to making a real impact on people’s lives. We build products for everyone and do not discriminate on gender, ethnicity, sexual orientation, religion, civil or family status, age, disability, or race.
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