Clinical Affairs Manager

The Clinical Affairs Manager is a senior individual contributor responsible for planning, executing, and reporting company-sponsored clinical studies to support IVD product submissions and post-market obligations. This role involves building and operationalizing the company’s Clinical Affairs infrastructure, including SOPs and vendor oversight practices, while serving as a key liaison between Regulatory Affairs, Medical Affairs, and other internal stakeholders. The position requires direct hands-on experience running sponsor-side clinical studies under applicable frameworks and authoring clinical sections of regulatory submissions.