The Sr. Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical, Inc. (SWMI). The Sr. Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, ma

will include Ability to communicate scientific or medical information to lay audiences in a clear and concise manner. Ability to interpret clinical and other complex information and data and capable of teasing out relevant proof points for key stakeholders. Demonstrates knowledge in understanding commercial, product, technical and clinical aspects of calcium market, includ

The Staff Manufacturing Engineer is responsible for providing engineering support to Production. Also responsible for designing, developing, testing, and implementing processes, tooling, and fixtures for commercial product. In addition, theStaff Manufacturing Engineer will sustain activities on the production line such as raw material, process and equipment issues. Essent

The Sr. Clinical Research Associate (Sr. CRA) will be responsible for establishing, managing and meeting milestones of clinical studies in compliance with applicable clinical and regulatory standards and in alignment with business needs. They will be accountable for clinical project management activities, for coordination with cross functional counterparts and contract re

The Senior Principal Business Analyst will be responsible for the design, implementation, and support of the Order Management functionalities of Shockwave's Oracle Cloud ERP solution. The ideal candidate is experienced in implementing Oracle cloud implementations specific to Order Management, Master data such as Customer, Pricing and can address the business needs by effe

The Principal Administrative Assistant will provide assistance to the VP of Quality and other Sr. Staff, Quality Leadership and other members of the Quality Team as needed. In this position, the Principal Administrative Assistant will be responsible for providing administrative support on a day to day basis. This includes clear communication; discrete handling of confiden

Facilities & Environmental, Health, and Safety (EHS) are critical to the day to day operations and safety of our employees and protection of our environment. We are seeking an intern that will work on setting up Facilities & EHS systems and portal page globally. We expect this position to have these projects complete by the end of their internship. Essential Job Functions

The Senior Analyst in Supply Chain will focus on driving continuous improvement across our entire supply chain. The role will need to have hands on experience in end to end Supply Chain Operations, including planning, forecasting, procurement, warehousing network, inventory management and operational expenditure. The role will collect and analyzes data to help improve an

We are searching for a talented and experienced Modern Data Stack Data Engineer to join our growing team. You will be responsible for designing, building, and maintaining data pipelines using technologies like Fivetran, Azure Data Factory and Python into our Snowflake data warehouse and transforming the data using tools like dbt and Coalesce. You will also be responsible

We are looking for a senior hands on person in Oracle cloud with core expertise in Record to Report track that encompasses Cash management, Fixed Assets and General ledger modules. This role will also be working on the system design and integrations related to other boundary systems that has direct impact on R2R modules. Essential Job Functions This role will be the prima

As the Senior Director of Technical Delivery, you will lead the strategic and operational management of our Enterprise Applications technology. This role will be responsible for all horizontal engineering services, including Development, QA, DevOps, Enterprise Architecture, Integration Engineering, and Platform Resilience. This role is critical in supporting our mission b

The Regulatory Affairs Specialist is an individual contributor who will help secure and retain global regulatory approvals for medical devices by archiving, creating, and maintaining specific categories of regulatory documentation and data. The function of the Regulatory Affairs Operations Specialist is to provide submission publishing/verification support, and Regulatory

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure wave

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure wave

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure wave