Head of Clinical and Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Head of Clinical and Regulatory Affairs based in the United States.

This role provides strategic and operational leadership across Clinical Affairs, Clinical Operations, Clinical Science, and Regulatory Affairs for an innovative medical device platform.
You will own the clinical lifecycle end-to-end, with an immediate focus on executing complex multi-site trials for implantable neuromodulation technology.
The position combines clinical execution, regulatory strategy, evidence generation, team leadership, and cross-functional product development.
You will work closely with executive leadership, R&D, Quality, Operations, Marketing, CROs, clinical sites, and regulatory authorities to advance programs efficiently.
A major focus will be building a scalable clinical and regulatory organization capable of operating with high autonomy as the company grows.
This is a highly visible opportunity to shape clinical strategy, engage leading experts, and contribute to the development of technologies designed to address significant unmet needs in mental health.