Opportunity Description
Leo Cancer Care: VP of Regulatory Affairs
Location: Crawley, West Sussex
Department: QA/RA
Position summary
The VP of Regulatory Affairs is responsible for the quality and regulatory activities of the organization, including the Quality Management System (QMS) and products in accordance with international standards, best practice and customer requirements.
Relevant Knowledge and Skill requirements
Establish and maintain an effective Quality Management System (QMS) in accordance with all applicable medical device regulations, including ISO 13485, US FDA Quality Systems Regulation (QSR), and Medical Devices Single Audit Programme (MDSAP). Lead Continuous Improvement of the Quality Management System. Input to regulatory aspects of technology & product opportunity evaluation. Lead quality and regulatory aspects within the product development process, e.g., standards. Identification and interpretation, quality and regulatory resou...
Location: Crawley, West Sussex
Department: QA/RA
Position summary
The VP of Regulatory Affairs is responsible for the quality and regulatory activities of the organization, including the Quality Management System (QMS) and products in accordance with international standards, best practice and customer requirements.
Relevant Knowledge and Skill requirements
Establish and maintain an effective Quality Management System (QMS) in accordance with all applicable medical device regulations, including ISO 13485, US FDA Quality Systems Regulation (QSR), and Medical Devices Single Audit Programme (MDSAP). Lead Continuous Improvement of the Quality Management System. Input to regulatory aspects of technology & product opportunity evaluation. Lead quality and regulatory aspects within the product development process, e.g., standards. Identification and interpretation, quality and regulatory resou...
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