Mitra Bio in London is seeking a Regulatory Affairs & Quality Manager to lead regulatory and quality activities for our melanoma diagnostic programme, including a non-invasive sampling device and a sequencing-based test. You will prepare technical documentation, manage our QMS, and act as Mitra Bio’s regulatory contact with UK and EU authorities, Notified Bodies and partners.
You’ll ensure regulatory requirements are incorporated throughout development and that evidence meets submission
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Regulatory & Quality Lead, Medical Devices/IVD (12M) in London employer: Mitra bio
Mitra Bio is an exceptional employer, offering a dynamic and innovative work environment in the heart of London. As a Regulatory Affairs & Quality Manager, you will play a pivotal role in advancing groundbreaking melanoma diagnostic technologies while benefiting from a supportive culture that prioritises employee growth and inclusivity. With opportunities for hands-on involvement in regulatory processes and a commitment to professional development, Mitra Bio stands out as a rewarding place to build your career in the medical device sector.