Summary: The role of IVD SaMD QA Consultant involves leading clinical validation and regulatory processes for a biotech company specializing in immune profiling and precision diagnostics. The position requires expertise in IVD product development and SaMD development, ensuring compliance with regulatory requirements throughout the product life cycle. This is a full-time position on a 12-month contract basis. The company is experiencing growth and seeks to enhance its IVD expertise following a successful funding round.

Key Responsibilities:

• Lead clinical validation and regulatory processes for the company's platform.
• Ensure compliance with regulatory requirements and Quality Management System (QMS).
• Support regulatory submissions throughout the product life cycle.
• Manage projects in a regulated environment related to IVD and SaMD development.

Key Skills:

• Expertise in IVD product development.
• Experience in SaMD development.
• Strong project management skills in a regulated environment.
• Knowledge of clinical validation processes.
• Understanding of regulatory compliance and submissions.

Salary (Rate): 95,000

City: London

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: Senior

Industry: Other