Description

About Us

We expedite access to precision medicine clinical trials for patients globally. Our team of experts with unparalleled domain knowledge and global relationships enables us to deliver compliance excellence in the precision medicine sector.

As a Belfast-based Clinical Research Organisation, we specialise in delivering compliance solutions to companies in the precision medicine sector. We support leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification.

Job Description

To be an integral member of our project team(s), you will ensure that client objectives are met and exceeded at all times. This requires a platinum standard approach to regulatory research, internal and external stakeholder satisfaction, and a work ethic aligned with our core values.

Main Responsibilities:

• Provide specialised regulatory expertise to client companies, ensuring internal procedures and client expectations are met.
• Bring considerable experience in IVD/CDx development, validation, and approval to client organisations.
• Research and prepare elements of regulatory submission documents on behalf of client companies.
• Assist the wider team in understanding regulatory requirements for investigational devices.

Requirements:

• Engineering or Scientific honours degree or equivalent (10+ years) relevant industry experience.
• 5+ years experience working in a medical device/IVD manufacturing or regulatory environment.
• Experience with IVD/CDx design and development, from feasibility to approval.
• Knowledge of regulations in key global markets as they pertain to IVD and/or CDx devices.

Estimated Salary: £60,000 - £80,000 per annum