Regulatory Operations Specialist

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 OverviewThe 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 compliance support.Essential Job FunctionsVerify and quality review of submissions and other responses to regulatory agenciesPublish worldwide regulatory submissions in compliance with geography-specific regulatory requirementsArchive correspondence sent to and received from Regulatory Agencies and Notified BodyTrack original and renewals of annual licenses and registrations/listings, and collect/organize/ disseminate, when required, registration renewal documentationAuthor and route document change orders via document control systemProvide other country specific regulatory supportNotarize business documentsProcure document authentications, legalizations, and certificationsContribute to process improvement projectsMaintain the Department intranet up to dateEnsure personal compliance with applicable company policies and proceduresProvide audit backroom supportOther duties as neededRequirementsBachelor's degree or equivalent experience. Bachelor's degree in science, math, engineering, or medical fields is preferred.Minimum 2 years of experience in a regulatory position in a regulated healthcare industry or equivalent.Ability to work collaboratively in a fast-paced environment while managing multiple priorities.Highly proficient with MS Word, SharePoint (or equivalent), Excel, Adobe and Power Point. Proficient with Word Macros.Flexible with changing priorities, ability to manage multiple tasks, prioritize and schedule work to meet business needs and timelines.Organized, detail oriented, with good planning and time management skills.Ability to complete short- and long-term projects of moderate complexity with some guidance.Exercise sound and ethical judgment within policy and regulations.Ability to think analytically with good problem-solving skills.Clear and effective verbal and written communication skills with various levels of the organization.Notary Public is a plus.Market Range:

$83,000 - $104,000Exact compensation may vary based on skills, expertise, and location.BenefitsShockwave Medical offers a competitive total compensation package as well as the following benefits and perks:Core Benefits:

Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balancePerks:

ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awardsEEO Employer

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