QARA Officer Technical Writer

CK Group are recruiting for a QA / RA Officer to join a medical diagnostics company at their site, based in Gateshead, on a permanent basis.

The role

You will be part of a fast-paced, long-term project as our client transition all of their products into full IVDR compliance and bring new products to the market.

You will assist in completion of IVD Medical Device Registrations, continuously support the Registration Processes, Quality Assurance & Regulatory Affairs Processes and assist in ensuring that devices are in compliance with their Technical Documentation.

Other duties and responsibilities include:

• To play your part in ensuring that the requirements of Regulation (EU) 2017/746 (IVDR) are met by the company.
• To conduct Technical Writing as co-ordinated by the Technical Compliance Manager.
• To be proactive in your approach to completing documentation required for Technical Compliance with respect to the IVDR.
• Co-Ordination and preparation of Technical Documentation and Declarations of Conformity for the EU.
• To maintain high levels of integrity, professionalism & regulatory compliance.
• To be responsive to ad-hoc requests from QA/RA Management and from the Technical Compliance Manager.

Your background:

• 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).

For more information, or to apply for the position, please contact Georgia Barnes onor , quoting job ref 106804.

Entitlement to work in the UK is essential.