Quality System Engineer (m/f/d) with DHT Technical Capabilities

Digital Health Technologies (DHTs), including those with medical device capabilities, are critical for enhancing patient value. To address the varying measurement needs across our clinical trials, we partner with multiple third-party DHT manufacturers. While DHTs are necessary to provide critical evidence to support medical decision making, they add complexity to study delivery and require different technical skills. Addressing these complexities necessitates specialized support to assess regulatory identity, manage technical documentation, review manufacturer data, and coordinate change control activities.

A limited number of internal experts possess the technical skills (or DHT Technical Capabilities) required to manage regulatory identity assessments, documentation needs, and change control, leading to bottlenecks that delay study starts and risk the successful integration of DHTs.

We seek a dedicated quality systems engineer consultant to provide additional DH...