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This role involves leading the regulatory strategy for a cardiology medical device company, focusing on FDA, CE, and UKCA submissions, and ensuring compliance with international regulations. You will work closely with the senior team and regulatory bodies, driving the company's expansion into new markets.
The Data Sharing Manager is responsible for managing and overseeing the end-to-end process of internal and external data sharing requests, ensuring compliance with privacy standards and procedural requirements. The role involves supervising vendors, managing YODA Project requests, and providing support to external research teams using J&J clinical study data.
The Data Sharing Manager is responsible for managing and overseeing the end-to-end process of internal and external data sharing requests, ensuring compliance with privacy standards and procedural requirements. Key responsibilities include vendor oversight, YODA Project management, and supporting external research teams using J&J clinical study data.
The Manager Clinical Data Transparency, Data Sharing role involves managing and overseeing the end-to-end process of internal and external data sharing requests, ensuring compliance with privacy standards and procedural requirements. Responsibilities include supervising vendors for data anonymization, managing YODA Project requests, and supporting external research teams using J&J clinical study data.
The Senior Analyst role involves validating and adopting global PLAN business processes for the Transcend EMEA-OTC releases. Key responsibilities include driving process scoping, testing, and quality assurance, ensuring operational readiness, and facilitating continuous process improvements.
The Senior Analyst role involves validating and adopting global PLAN business processes for the Transcend EMEA-OTC releases. Key responsibilities include driving process scoping, testing, and quality assurance, ensuring operational readiness, and facilitating continuous process improvements.
A little outside Southampton, but within reach.
The Quality Engineer will maintain and improve the Quality Management System, conduct internal and external audits, ensure regulatory compliance, and lead quality improvement projects. The role involves working in a regulated medical device environment, collaborating with stakeholders to embed practical quality processes.
This role involves maintaining and developing the Quality Management System (QMS) in a high-end cleanroom environment, ensuring compliance with ISO 9001/13485 and AS9100 standards. You will work within a team of 6, using tools like CAPA, 8D, and 5 Whys to drive quality standards and influence change.
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