Director, Clinical Affairs
Blackrock Neurotech - Salt Lake City, UT
Hiring: Director, Clinical Affairs Company: Blackrock Neurotech Location: Salt Lake City, UT Job Posted Time: 2026-09-10 11:19:11 Employment Type: Remote Target Skills & Keywords : Product Management, R, Regulatory Compliance About the job Experience: •10+ years of progressively responsible clinical development or clinical affairs experience within the medical device industry •3+ years of demonstrated leadership experience, including experience leading or building clinical teams Required Skills: •Clinical Strategy & Development •Develop and execute the company's overall clinical development strategy aligned with R&D, regulatory and commercial objectives •Translate product-development objectives into appropriate clinical evidence strategies for investigational and commercial-stage products •Develop clinical strategies for early feasibility studies (EFS), IDE programs, pivotal investigations, and post-market clinical activities, as appropriate •Define clinical development plans, evidence requirements, milestones, timelines, and resource requirements for individual products •Interface directly with Regulatory Affairs to develop clinical strategies that support FDA and global regulatory submissions •Ensure clinical strategies are appropriately aligned with the intended use, risk profile, regulatory classification, and stage of product development •Clinical Study Design & Execution Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!