The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact well with the HeartFlow Clinical Research staff and collaborate effectively with HeartFlow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast- paced start-up culture.

As a Senior Officer Regulatory, you will manage a portfolio of grants optimizing regulatory systems for medical products in Foundation focus countries, primarily in sub-Saharan Africa. You will support the establishment of an agile African Medicines Agency and the foundation's partnership with the WHO, facilitating the development and implementation of grants and strategies, all while ensuring high-quality interactions and clear communication with grantees and partners.

Assisting Managers with clinical pends and over-read feedback, assigning manual assignments, and aiding individual data entry production, while reviewing daily QA reports, this role ensures collaboration among cross-functional teams for product releases. Additional duties are necessary to meet client obligations.

As the Director/Sr. Director, Regulatory Affairs, the candidate will be a driven global regulatory leader with expertise in regulatory strategy development and execution, navigating global health authority interactions, leading cross-functional teams, and driving clinical and licensing submissions.

Identify regulatory requirements related to the product and implement best practices for monitoring, interpreting, and communicating changes to internal teams. Proactively monitor, investigate, interpret, and communicate changes to regulatory requirements that may impact the current product. Work directly with product management to translate regulatory requirements into Veeva’s framework for use within our suite of applications.

Provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products. This person will work with confidential subjects and company data, and interface with a variety of internal and external stakeholders. The Sr. Clinical Study Manager understands business environment and relates extensive knowledge of internal and external activities to trends.

Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. Demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements. Assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs. Supports products within the Oncology TA.