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Quality Assurance and Regulatory Affairs Officer

2 months ago

Gateshead, Gateshead, United Kingdom CK Group Full time
About the Role

We are seeking a highly skilled Quality Assurance and Regulatory Affairs Officer to join our team at CK Group. As a key member of our team, you will play a crucial role in ensuring that our medical diagnostics company meets the requirements of Regulation (EU) 2017/746 (IVDR).

Key Responsibilities
  • Assist in the completion of IVD Medical Device Registrations and support the Registration Processes, Quality Assurance & Regulatory Affairs Processes.
  • Ensure that devices are in compliance with their Technical Documentation.
  • Conduct Technical Writing as coordinated by the Technical Compliance Manager.
  • Be proactive in completing documentation required for Technical Compliance with respect to the IVDR.
  • Coordinate and prepare Technical Documentation and Declarations of Conformity for the EU.
  • Maintain high levels of integrity, professionalism & regulatory compliance.
  • Be responsive to ad-hoc requests from QA/RA Management and from the Technical Compliance Manager.
Requirements
  • Some experience and background in Medical Device or Pharmaceutical Quality Management and/or Regulatory Affairs Department and/or Technical Writing.
  • A Scientific Background.
  • Knowledge and Awareness of Quality Management Systems, e.g. ISO 13485, ISO 14971 and the US Quality System Regulation.
  • Knowledge and Awareness in Standards & Regulatory Requirements according to ISO 13485:2016, IVDD (98/79/EC), IVDR 2017/746 and other applicable standards and regulations as directed by the Associate Director of QA/RA.
  • Knowledge of Good Manufacturing Practices (GMP).
  • Knowledge of non-conformity investigation skills.
  • Clear attention to detail with regards to existing and new documentation.
  • Competent in the use of Internet, Microsoft, Windows programs including Word, Excel, PowerPoint, and other software solutions pertinent to the role (electronic QMS software, IMS software).
About CK Group

CK Group is a leading provider of quality assurance and regulatory affairs services to the medical diagnostics industry. We are committed to delivering high-quality services that meet the needs of our clients.