This temporary 12-month position (for maternity cover) reports to the Manager of Quality Assurance (Design) and is part of the Quality Assurance and Regulatory Compliance Department located in Newcastle-upon-Tyne and will be an on-site position.
In this role, you will have the opportunity to:
* Work on site projects to support the progression of the most viable commercial/strategic opportunities for New Product Development (NPD) or Product Lifecycle Management (PLCM)
* Plan, organise and conduct duties related to design assurance and ensuring executions of tasks ensuring the delivery to the business is within budget and on schedule
* Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA 510(k)s and PMAs and IVDR CE certifications
The essential requirements of the job include:
* Working knowledge of design controls for regulated products
* Experience in IVD medical device new product development and design controls
* Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820 and ISO 13485
* Bachelor’s degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance
It would be a plus if you also possess previous experience in:
* Experienced with higher classification IVD/Medical devices and companion diagnostics
* IVD medical device regulatory affairs experience a distinct advantage
* Experience with the MDSAP Programme