Regulatory Affairs & Quality Manager – Medical Devices / IVD

12-month fixed-term contract | Hybrid - London

Company description

Mitra Bio has developed a non-invasive skin sampling that can detect molecular changes in the skin non-invasively. The Company has been awarded the prestigious European Innovation Council grant to develop a non-invasive molecular test for screening moles suspected of melanoma.

As we continue to grow, we’re looking for a Regulatory Affairs & Quality Manager – Medical Devices / IVD to lead our regulatory and quality activities for our melanoma diagnostic programme and support the successful launch of our medical device and diagnostic products in the UK and EU.

This is a 12-month fixed-term contract with the opportunity to increase the commitment as the programme develops.

You’ll lead the regulatory and quality activities for Mitra Bio’s melanoma diagnostic programme, which includes a non-invasive sampling medical device and a next-generation sequencing-based molecular test for cancer.

This is a hands-on role for someone who has previously taken a medical device or IVD through regulatory approval and to market. You’ll lead the preparation of technical documentation and regulatory submissions, develop and maintain our Quality Management System, and act as Mitra Bio’s key regulatory contact with external regulatory bodies and partners.

You’ll work closely with our product, scientific and clinical teams to ensure regulatory requirements are incorporated throughout product development and that our clinical and analytical evidence meets submission requirements.

You’ll be responsible for:

• Leading the regulatory activities to achieve CE marking of Mitra Bio’s melanoma diagnostic test and sampling device in compliance with IVDR and MDR
• Developing, implementing and maintaining Mitra Bio's Quality Management System in accordance with ISO 13485
• Leading preparation of technical documentation and regulatory submissions under applicable UK and EU medical device and IVD regulations
• Managing interactions with relevant regulatory authorities, UK Approved Bodies, EU Notified Bodies and other external regulatory partners
• Leading or supporting product and organisational registrations, including EUDAMED and relevant UK requirements
• Providing regulatory oversight of verification and validation activities, ensuring clinical and analytical evidence meets submission requirements
• Establishing appropriate post-market surveillance, complaints handling and regulatory reporting processes
• Advising product, scientific and clinical teams on regulatory requirements throughout product development
• Ensuring regulatory requirements are translated into practical development plans, documentation and milestones
• Liaising with the hospitals, clinical trials team and stakeholders to ensure the smooth operation of our melanoma diagnostic programme

About you

You’re an experienced Regulatory Affairs and/or Quality Assurance professional with a strong background in IVDs and hands-on experience taking medical devices or IVDs through regulatory approval.

You have strong working knowledge of EU MDR and/or IVDR and ISO 13485 , and you’re comfortable taking hands-on ownership of regulatory and quality activities.

You should apply if you have:

• Significant professional experience in Regulatory Affairs and/or Quality Assurance within the IVD industry
• Hands-on experience with EU medical device regulatory approvals and CE marking under EU MDR and/or IVDR, with preference for experience with high-complexity Class C IVDs
• Strong working knowledge of ISO 13485 and medical device quality management systems
• Experience preparing and managing technical documentation and regulatory submissions
• Experience working directly with regulatory authorities, Approved Bodies and/or Notified Bodies
• Strong understanding of verification, validation, clinical evidence and post-market requirements
• The ability to operate independently in an early-stage startup environment and take ownership from strategy through execution

It would be particularly useful if you also have:

• Experience with FDA regulatory pathways, including pre-submission meetings and/or 510(k) submissions
• Familiarity with genomics, next-generation sequencing or molecular diagnostic workflows
• Experience establishing or scaling a QMS within an early-stage biotechnology or diagnostics company

Mitra Bio is committed to building a diverse and inclusive team, and we welcome applications from people of all backgrounds, experiences and perspectives.

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