Quality Assurance & Regulatory Affairs Manager

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 and Regulatory environments
• Background within medical devices
• Solid understanding of ISO13485 and 510K FDA submissions
• Experience working cross-functionally with technical and operational teams
• A detail-focused, methodical approach with strong organisational skills

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