Title: QA/RA Officer
Salary: Depending on experience
Location: Northeast
Contract & Start-Date: Full-time, Permanent. ASAP.
Are you looking for opportunities to work in Quality & Regulatory functions in the medical device industry? There is a fantastic opportunity to join an exciting team and contribute to working to IVDR and ISO 13485 standards, supporting with technical documentation, regulations, QMS management and more.
As a QA/RA Officer, you will be responsible for supporting the management of QMS, technical documentation maintenance relevant to relevant regulations and guidelines (ISO 13485, IVDR). As well as supporting with audits, risk management and other wider business functions.
Your Responsibilities will include:
- Ensure that IVDR and other regulations are met by the company.
- Completing technical documentation and technical writing where required, and for compliance with IVDR.
- Conduct and participate in self-development and continuous professional development where required.
- Be willing to work on requests from QA/RA management and technical compliance management.
- Be proactive and show initiative regarding time management, work-prioritisation and committing to time-critical tasks.
- Work cross functionally with other teams and functions across the business.
- Involvement in risk management of IVD medical devices both new and old. Safety sheet generation, review, preparing and supplying documentation to facilitate sales of IVD medical devices.
- Supporting with internal audits, post market surveillance and follow-ups. As well as training of colleagues.
- Conduct literature reviews and provide data and feedback to technical and regulatory teams.
About you:
- Possess a knowledge and understanding of Quality Management Systems (QMS) such as ISO 13485. As well as Standards and Regulations according to ISO 13485, IVDD and IVDR.
- Knowledge of GMP and non-conformance investigations.
- Excellent attention to detail regarding existing and new documentation.
- Competent in the use of internet, softwares windows programmes and other technology.
- A relevant degree in a scientific discipline.
- Experience or knowledge of Electrophoresis or IVD medical devices. As well as preparation of technical documentation, QA or regulatory functions within relevant disciplines.
If you’re interested in applying to this opportunity or learning more, get in touch at: kieran.martin@cypartners.co.uk