Quality Consultant

1 month ago


United Kingdom elemed Full time

Title: Regulatory Affairs Consultant - UKCA Location: Remote / UK
⌛ Contract length: A dynamic IVD company is at the forefront of innovation with cutting-edge technology and a state-of-the-art laboratory featuring a proprietary system and unique processes. Their fully digital, standardized, and AI-powered workflow enhances image quality and significantly reduces response times for clinics and patients. They provide services to both public and private healthcare providers.

Evaluate UK-specific regulatory requirements for transporting patient samples.
Conduct gap analysis for CE to UKCA transition.
Support UKCA approval for the digital pathology application.

Role - Regulatory Affairs Consultant with expertise in UKCA

Expertise in UK medical device and IVD regulations, including UKCA
Specialised in medical device regulatory pathways, particularly for digital health technologies and software as a medical device (SaMD)
Experience in conducting gap analysis and developing QMS and technical documentation for UKCA

Regulatory strategy outline during Sept – Oct 2024
Regulatory process and UKCA file compilation, will take place during Q1 2025
We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow.

At Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices.

⚖️ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.



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