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.