Clinical and Regulatory Lead

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Requirements:

• Education: Advanced degree in Medicine, Science, or related fields.
• Experience: Extensive experience in digital health, clinical governance, and leading large-scale, innovative medical projects. Prior roles in UK&EU clinical operations are highly regarded.
• Skills: Expertise in clinical research management, regulatory submissions, and evidence synthesis. Strong leadership and communication skills are essential.
• Attributes: Proactive, strategic thinker with a robust analytical capability and the ability to work in fast-paced, innovative environments.

Responsibilities:

• Design and lead the execution of research studies to establish the efficacy and safety of medical devices.
• Lead the creation and updates of clinical and regulatory documentation.
• Develop strategies for clinical trials that align with product and regulatory development goals.
• Collaborate with cross-functional teams to integrate clinical research insights into product planning and commercial strategies.
• Ensure compliance with regulatory standards (e.g., EUMDR, UKMDR) and maintain high standards of clinical governance.
• Engage with global stakeholders, including healthcare providers, and academic institutions, to foster partnerships and advance research objectives.