My client, an innovative technology business within the medical device sector, are seeking a Quality Assurance & Regulatory Affairs Manager to join their team.
Working closely with senior leadership, R&D and operations, you will play a pivotal role in bringing products to market efficiently and compliantly.
Key responsibilities will include but are not limited to:
* Leading and developing the company’s Quality Management System
* Managing change control activities across products, processes and documentation
* Overseeing product and process validation activities in collaboration with technical teams
* Ensuring effective quality control processes across materials and finished products
* Driving compliance across risk management, CAPA and audit activities
* Supporting regulatory submissions and maintaining compliance across EU and US markets
* Acting as a key contact for regulatory bodies and external stakeholders
* Managing post-market activities, including complaints and ongoing product compliance
The successful candidate will have:
* Strong experience within Quality Assurance / Regulatory environments
* Background within medical devices, diagnostics or a regulated manufacturing setting
* Solid understanding of ISO12485 and 510K FDA submissions
* Experience working cross-functionally with technical and operational teams
* A detail-focused, methodical approach with strong organisational skills
If this opportunity sounds like the right next step for you, please contact Liam for more information or click apply now.
We aim to respond to every applicant. However, if you have not heard from us within 10 days, please assume that on this occasion your application has been unsuccessful or the role has now been filled. You are welcome to contact our office or email us to discuss other opportunities