Regulatory Affairs Consultant – Digital Health / DHT (Contract)

Medical Devices | Global Pharma | Remote

We are supporting a global pharmaceutical organisation in its search for a highly specialised Regulatory Affairs Consultant to provide expert support on the use of FDA-like Digital Health Technology (DHT) and digital biomarkers, with a particular focus on China, Korea and Japan regulatory strategy.

This is a 6-month consulting engagement, suited to an experienced regulatory specialist operating in a true consultant model rather than a permanent hire.

Scope & Responsibilities

• Advice on the regulatory use of FDA-like Digital Health Technology (DHT) in China
• Support the development and refinement of regulatory presentations and submission materials
• Provide input into CTA-related activities, including CTAs involving digital biomarkers or DHT
• Work closely with internal Regulatory Affairs and Product Management teams
• Support (but do not lead) regulatory submissions
• No responsibility for client-facing presentations

Key Requirements

• Strong background in Regulatory Affairs for medical devices
• Experience with CTA processes, ideally involving digital biomarkers or DHT
• Prior exposure to China regulatory pathways is highly desirable
• Experience working at the interface of pharma and medical devices preferred
• Ability to operate independently in a consulting capacity
• Specialist-level expertise suited to short, focused, high-impact engagements