Adecco LifeSciences are recruiting for a Quality Regulatory Specialist to support a leading diagnostics business.
The QA/RA Specialist will work closely with the Director of Quality & Regulatory Affairs to assist in maintaining a compliant quality environment and supporting the submissions of their product portfolio globally.
This opportunity will allow you to work within a small team, being hands-on in all areas of the QARA department with dedicated support and training throughout your career there.
You will be focusing on working collaboratively with the wider QARA team to complete the IVDR transition, ensuring technical files are compliant prior to the Notified Body inspection.
Alongside this, you will be working with distributors to register products globally this will include APAC and the US.
Day to day you will:
*Help drive the country product registration submission process
*Review documentation and work cross-functionally to ensure all processes comply with the relevant standards and regulations.
*Provide guidance on Risk Management activities to ensure compliance with ISO 14971.
*Maintain the Non-Conformance/Deviation system and perform Root Cause Analysis into CAPA investigations.
*Assist in the review of Technical, Medical Device and Design History Files.
*Perform internal Audits and participate in external Inspections and Audits with clients, distributors and Notified Bodies.
*Provide support and guidance for new product development projects/throughout the design control process.
You will need previous experience working with IVD's and ideally experience with IVDR to be considered for this position.
You will have at least 3 years of quality and regulatory exposure.
You will have worked to create and maintain technical files for global product submissions.
If this position is of interest, please get in touch and we can discuss the next steps.
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