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.

The Global Regulatory Compliance Lead is responsible for leading assigned Regulatory Compliance activities, including activities related to the procedural document creation and updates, audit and inspection execution and preparation and regulatory risk management. The role will also support the Global Regulatory Affairs department with various operational quality and compliance activities, as well as training assignments and follow-up.

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.

Assist in the execution of Clinical Trials by providing administration, coordination and organizational support to the Clinical Study Lead. Manage multiple priorities consecutively and sequentially, meeting quality standards for accuracy, attention to detail and timelines. Help define various aspects of clinical trials to ensure timely completion, efficient protocols, budget alignment, and compliance with ICH/GCP Guidelines.

The Post-Market Surveillance Report Specialist provides expertise and support for the development of post-market strategies, plans, and reports for new and existing Intuitive products. This team member will work with cross-functional teams in the development of post-market strategies and create documentation including the plans and reports (e.g. PMS Plans, Periodic Safety Update Reports (PSURs)), which support regulatory approvals and compliance. The role will require close partnership with cross-functional teams including Regulatory Affairs, Quality Engineering/Assurance, Risk Management, Medical Science, Clinical Affairs and Medical Affairs.

The Nursing Regulatory Affairs Analyst manages gathering, organizing, and analyzing regulatory data and resources, interacting with internal and external stakeholders such as state and national Boards of Nursing to review and record rules, regulations, statutes, and advisory opinions in the development of resources for internal use. This position supports new program Board of Nursing applications and regulatory surveys or reports.

Positively contribute to the regulatory probability of success for clinical and commercial therapeutic programs. The Regulatory CMC Lead will oversee CMC Regulatory Affairs, working closely with subject matter experts and providing product strategy to commercial and clinical teams. Facilitate risk identification & mitigation strategies and oversee activities of junior regulatory personnel.

This position is responsible for providing Regulatory CMC strategies and leading the preparation of submissions and health authority interactions. Support development and execution of global Regulatory CMC strategies for Kyverna’s CAR T therapies, ensuring alignment with corporate objectives/timelines and regulatory compliance. Author and/or review high quality CMC sections for global regulatory submissions (IND/CTA, and BLA/MAA), applying agreed CMC global regulatory strategies, current regulatory trends, and guidelines.

The Clinical Trial Manager will be responsible for managing all aspects of clinical trials from start-up through close-out, providing functional expertise to ensure that study timelines, costs and quality metrics are met and the study is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements.

Lead the development and execution of regulatory strategies for Europe, ensuring alignment with corporate objectives and timelines. Drive the planning and coordination of regulatory submissions and interactions with European health authorities. Oversee the preparation, review, and compile European-specific regulatory submissions. Utilize in-depth knowledge and experience in European regulatory affairs.