Deputy QA and Regulatory Affairs Manager
Salary Dependent on Experience
CY Partners are working with a leading medical diagnostic company to help recruit a Deputy QA and Regulatory Affairs Manager for a permanent role at their head office in Gateshead. The client in question specialises in the design, manufacture and support of Clinical Electrophoresis and Haemostasis systems.
The responsibilities of this role will include:
- To meet IVDR and IVDD compliance and the ISO standard.
- To act as an approver of production documentation and associated artwork/documentation used by the end customer and for internal use, and to make the documents effective, where outside Q-Pulse if required.
- To act as an approver of site and departmental standard operating procedures, and to raise new procedures where necessary.
- To manage and facilitate with all global registration related activities, including producing country specific documents where required and acting as signatory on behalf of the company.
- To assist with the maintenance of the site Quality Management System, including updating of documentation and providing training where necessary, including site induction training.
- To manage all Safety Data Sheets (MSDS) and associated documentation, and advise on Dangerous Goods Transport.
- To maintain licence requirements with Home Office.
- Regular review and company notification of regulatory legislation and guidelines, other than IVDR 2017/746.
- Register new products and/or significant changes with relevant regulatory authorities
- Assess the impact of design changes for regulatory compliance and the implications for maintaining product registration.
- To work with the quality and production teams to ensure product regulatory requirements are met.
- Work closely with the Quality Manager to ensure product is released to the market only if quality and regulatory requirements are met.
- To maintain high levels of integrity and regulatory compliance.
- To ensure the company is Audit ready at all times.
- A strong background in the medical device or pharmaceutical regulatory affairs management
- Knowledge and experience of Quality Management Systems: ISO9001 and ISO13485 and the US Quality System Regulation
- Knowledge and experience in regulatory requirements according to ISO 13485, IVDD (98/79/EC), IVDR 2017/746 and FDA Quality Systems Regulation.
- Design and preparation of Standard Operating Procedures
- Sound working knowledge of Safety Data Sheet requirements
- Non-conformance investigation skills
To express an interest in this role, apply now or contact Charlotte on 07851246841 for more information.