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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 waves for the treatment of calcified plaque. Position Overview The Principal 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 Principal Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. Under direction of responsible Regulatory Affairs Management, works independently with minimal oversight, acts as a decision-maker on regulatory issues, assures that registration/renewal and other deadlines are met, and supports new product development, post-approval change management and J&J integration as assigned. Essential Job Functions Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units. Develop regulatory policies, processes and SOPs and may train key personnel on them. Lead and execute assigned integration projects. Lead implementation of continuous improvement updates to internal policy and procedures in response to changing regulations, standards, internal and external audits. Develop regulatory strategies and update strategy based upon regulatory changes. Determine submission and approval requirements in assigned geographies and effectively communicate application progress to internal stakeholders Provide input and technical guidance on regulatory requirements to product development and operations teams. Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents). Review and approve R&D, quality, preclinical and clinical documentation for submission filing. In collaboration with cross-functional team members, compile, prepare, review and/or submit regulatory submissions to authorities in and outside the US, as assigned (e.g., EU, Canada, Australia, Japan, etc.). Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals. Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements Oversee the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies. Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation. Provide regulatory input for product recalls and recall communications. Review and approve advertising and promotional materials to ensure regulatory compliance. Evaluate import/export requirement. Identify emerging issues. Provide other country specific regulatory support. Effectively and accurately write and edit technical documents. Plan and conduct meetings, create project plans and timelines, and manage projects. Exercise good and ethical judgment within policy and regulations. Perform multiple tasks concurrently with accuracy. Provide guidance to functional groups in the development of relevant data to complete a regulatory submission. Other duties as assigned. Requirements Typically requires a minimum of 10 years of related experience with a Bachelor's degree; or 8 years and a Master's degree