Medical Device Compliance Specialist
7 days ago
CK Group is seeking a highly skilled QA/RA Officer to join their team at a medical diagnostics company in Gateshead. The successful candidate will be part of a fast-paced project to ensure all products are in full IVDR compliance and new products are brought to market. Key responsibilities include:
* Assisting in the completion of IVD Medical Device Registrations
* Supporting Registration Processes, Quality Assurance & Regulatory Affairs Processes
* Ensuring devices are in compliance with Technical Documentation
Requirements:
* Experience in Medical Device or Pharmaceutical Quality Management and/or Regulatory Affairs Department and/or Technical Writing
* Scientific Background
* Knowledge of Quality Management Systems, e.g. ISO 13485, ISO 14971 and the US Quality System Regulation
* Competent in the use of Internet, Microsoft, Windows programs including Word, Excel, PowerPoint, and other software solutions pertinent to the role
If you have a strong background in Quality Management and Regulatory Affairs, and are proficient in Microsoft Office, we encourage you to apply for this exciting opportunity.
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Gateshead, Gateshead, United Kingdom CK Group- Science, Clinical and Technical Full timeCK Group, a leading provider of science, clinical, and technical services, is seeking a highly skilled QA/RA Officer to join their team. The successful candidate will be responsible for ensuring the quality and regulatory compliance of medical devices.Key Responsibilities:Assist in the completion of IVD Medical Device Registrations and support the...
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