Device Development Lead

Pay rate: £ p/h (depending on experience)

Overview

The Device Development Lead will play a key role in the design, development, and lifecycle management of medical devices and combination products (MDCPs). Operating within the Devices Centre of Excellence in Cambridge, the successful candidate will lead cross-functional teams from concept through regulatory approval across global markets.

Responsibilities

• Lead multi-disciplinary device development project teams throughout the full product lifecycle.
• Manage project scope, deliverables, schedules, quality, and costs.
• Oversee design development, concept evaluation, device specifications, verification, and validation.
• Apply design control and risk management principles.
• Collaborate with drug product development, manufacturing, quality, regulatory, and engineering teams.
• Support global regulatory submissions (IND, BLA, NDA, ANDA, MAA, C...