Job Description

🔎 Title: Regulatory Affairs Consultant - UKCA

📍 Location: Remote / UK

⌛ Contract length: 3-6 months

✉️ Contact: ahmed@elemed.eu

🔸 The company

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.

🔹 The Opportunity

Evaluate UK-specific regulatory requirements for transporting patient samples.
Identify and obtain necessary permissions and registrations.
Conduct gap analysis for CE to UKCA transition.
Build up QMS and technical documentation for UKCA.
Support UKCA approval for the digital pathology application.

🔹 Requirements:

Role - Regulatory Affairs Consultant with expertise in UKCA

Expertise in UK medical device and IVD regulations, including UKCA
Knowledge of MHRA processes and guidelines
Experience with the logistics of cross-border patient sample transportation
Specialised in medical device regulatory pathways, particularly for digital health technologies and software as a medical device (SaMD)
Expertise in CE marking processes and transition to UKCA marking
Experience in conducting gap analysis and developing QMS and technical documentation for UKCA

🔹 Timelines:

Regulatory strategy outline during Sept – Oct 2024
Regulatory process and UKCA file compilation, will take place during Q1 2025
Assistance in review of CE mark technical file during Q4 2024 and Q1 2025

✉️ If you are interested in this exciting role, please send your application directly to ahmed@elemed.eu

📲 Would you like to find out more about our open opportunities? Visit https://www.elemed.eu/vacancies/

Please note: Only candidates meeting the requirements set out in the role profile above, will be considered in the application process.

Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.

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🩺 Elemed is Europe’s leading MedTech technical recruiter. 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.

📣 We won Best International Recruitment Agency at the Recruiter Awards 2021.

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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