Clinical and Regulatory Lead

Job title

Clinical and Regulatory Lead

Department

Research And Regulatory Strategy

Job Summary

The Clinical and Regulatory Lead will lead the development and validation of Software as Medical Devices, particularly in the area of remote patient monitoring and telemonitoring, using rigorous clinical validation and innovative research initiatives. The role involves design, execution and oversight of clinical investigations, collaboration with healthcare, academic, and industry partners, and ensuring compliance with EU and UK medical device regulations, including MDR 2017/745 and UK MDR 2002 (UKCA). This position will also focus on regulatory submissions, clinical evaluations, and post-market surveillance.

Key Responsibilities

• Lead the design and execution of clinical studies or service evaluations, ensuring safety, efficacy, health and economics outputs of telemonitoring devices in line with MDR 2017/745, ISO 14155, and healthcare organisations (e.g., NICE) guidelines.
• Lead the creation and updates of regulatory documentation, including Clinical Evaluation Plans (CEP) and Clinical Investigation Plans (CIP), ensuring compliance with MDCG guidelines and other relevant regulatory frameworks such as the UKCA. This to be done in close collaboration with the Regulatory Affairs and Quality Assurance team.
• Engage with Health Innovation Networks, academic institutions, and clinical research organisations across Europe to foster partnerships and drive innovation in telemonitoring solutions.
• Collaborate with global healthcare and research organisations to generate clinical evidence, support regulatory submissions, demonstrate device safety and performance, and publish high-quality peer-reviewed publications.
• Ensure the ongoing collection of clinical evidence through post-market clinical follow-up (PMCF) activities in compliance with MDR 2017/745 and other relevant standards.

About you and experience

• Education: Advanced degree in Medicine, Science, or related fields.
• Experience: Minimum 4 years of experience in digital health, medical device regulatory affairs, and clinical operations, with a strong focus on compliance with MDR 2017/745 and UK MDR. Experience in large-scale clinical trials and medical device evaluations is essential. Proven experience in interacting with notified bodies and competent authorities.
• Skills: Proven expertise in managing clinical investigations, medical device regulatory submissions, clinical evaluations, and knowledge of EU and UK regulations including MDR 2017/745. Familiarity with ISO 13485 is desirable.
• Strong leadership, project management, and communication skills are essential.

Don’t worry if you don’t have all of the skills outlined on a job advert, we value diverse skill sets, and recognise that no one candidate will match all desired skills - we’d love to hear from you if think a role seems like an interesting opportunity for you!