Regulatory Affairs Specialist: Compliance Expert

7 days ago


Santa Clara, California, United States Shockwave Medical Full time
Job Description

At Shockwave Medical, Inc., we are a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.

We aim to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Key Responsibilities
  • Closely partner with internal departments to ensure efficient and effective meeting of assigned regulatory requirements.
  • Combine knowledge of scientific, regulatory, and business issues to guarantee compliance with geography-specific regulatory requirements.
Requirements
  • A minimum of 5 years' experience in a regulated healthcare industry or an equivalent combination of education and experience.
  • Advanced knowledge of FDA guidelines and regulations, particularly for product promotional activities.
  • The ability to communicate effectively and collaborate with cross-functional teams.
  • Strong analytical skills and attention to detail.
Estimated Salary Range:$92,000 - $114,000Benefits

We offer a competitive total compensation package, including core benefits such as medical, dental, vision, pre-tax and Roth 401k options, short-term and long-term disability, and life insurance.

In addition, we provide perks like ESPP, Calm App, pet insurance, student loan refinancing, and spot bonus awards.



  • Santa Clara, California, United States Abbott Laboratories Full time

    Company OverviewAbbott Laboratories is a leading global healthcare company that focuses on developing innovative medical devices and treatments to improve patients' lives.We are committed to delivering high-quality products and services while ensuring compliance with regulatory requirements.SalaryThe estimated annual salary for this position is $95,400 -...


  • Santa Clara, California, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott is a global healthcare leader that empowers individuals to live their best lives. Our diverse portfolio of innovative technologies and solutions spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and pharmaceuticals.OverviewWe are committed to delivering...


  • Santa Clara, California, United States Abbott Laboratories Full time

    Regulatory Affairs Manager Role at Abbott LaboratoriesAt Abbott Laboratories, we're committed to helping people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.We're seeking a...


  • Santa Clarita, California, United States huMannity Medtec Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at huMannity Medtec. The ideal candidate will have a strong background in medical device development and a proven track record of ensuring regulatory compliance.Job SummaryThe Principal Regulatory Affairs Specialist will be responsible for participating on product...


  • Santa Clara, California, United States Collabera Full time

    Job OpportunityWe are seeking a highly skilled Regulatory Affairs Strategist to join our team at Collabera, a leading Global Digital Solutions Company.About the RoleThe successful candidate will be responsible for defining and implementing regulatory strategies and priorities in conjunction with management, peers, commercial, and affiliate personnel. This is...


  • Santa Clarita, California, United States Boston Scientific Full time

    About the Position:As a Regulatory Affairs Specialist II at Boston Scientific, you will play a crucial role in ensuring the company's products meet regulatory requirements worldwide. This is a hybrid position that requires minimum three days of office work per week, with a preferred location in Valencia, CA, and flexibility to be located in other US BSC...


  • Santa Clara, California, United States Abbott Laboratories Full time

    Company Overview">Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. With a portfolio of life-changing technologies spanning the spectrum of healthcare, our company offers leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.">Salary Range">The...


  • Santa Clara, California, United States Collabera Full time

    Job OverviewThis position is a highly visible role that plays a key part in the company's regulatory strategy and priorities.ResponsibilitiesAssists in defining and implementing regulatory strategies in conjunction with management, peers, commercial, and affiliate personnel.Communicates issues to management through project management tracking and issue...


  • Santa Monica, California, United States Neogene Therapeutics Full time

    About the RoleWe are seeking a highly skilled Cell Therapy Regulatory Affairs Manager to support the development and successful performance of our CMC regulatory strategy for innovative pipeline products.Key ResponsibilitiesInterpret global regulations and guidance to identify risks, providing input for cross-functional product teams.Partner with...


  • Santa Clara, California, United States Nesco Resource Full time

    Job Summary:A Senior Lab Supervisor position is available at Nesco Resource, overseeing the operations of research and development laboratories. The ideal candidate will ensure safety, compliance, and smooth operations within the team.Key Responsibilities:Process Development and Management: Develop or revise comprehensive documentation that meets...


  • Santa Ana, California, United States FISI - FUJIFILM Irvine Scientific Full time

    About FUJIFILM Irvine ScientificFUJIFILM Irvine Scientific, Inc. is a pioneering global leader in the development and manufacturing of cutting-edge cell culture solutions for Life Science and Medical markets. As a trusted partner to researchers, manufacturers, and clinicians worldwide, we provide innovative products and services that empower the advancement...


  • Santa Clara, California, United States Abbott Laboratories company Full time

    About UsAt Abbott, we're a global healthcare leader that helps people live more fully at all stages of life. Our diverse portfolio of life-changing technologies spans the spectrum of healthcare, from diagnostics and medical devices to nutritionals and branded generic medicines.We have 114,000 talented colleagues serving people in over 160 countries. At...


  • Santa Clara, California, United States Palo Alto Networks Full time

    Job Summary: We are seeking a highly skilled Global Cybersecurity Regulatory Expert to join our Product Counsel team at Palo Alto Networks.


  • Santa Rosa, California, United States Medtronic Full time

    About the RoleWe are seeking an experienced and highly motivated Senior Manager of Regulatory Affairs to play a crucial role in the development and execution of global regulatory strategies for innovative transcatheter valve technologies.Key ResponsibilitiesOversight of multiple team members working on innovative programs from concept design to market...


  • Santa Clara, California, United States Citrix Systems Inc Full time

    About Our TeamThe Global Compliance team at Citrix Systems Inc is a part of the Legal organization, responsible for policies, procedures, training, and controls for anti-bribery, anti-corruption, gifting, third-party due diligence, channels programs, and political compliance.This team drives global compliance training strategy, curriculum, and...

  • Compliance Counsel

    7 days ago


    Santa Clara, California, United States AESC US Full time

    AESC US LLC seeks a seasoned Compliance Counsel to join its team in the United States. As a key member of the organization, this individual will play a critical role in providing expert guidance on trade laws, export/import controls, sanctions, and anti-bribery/anti-corruption regulations.About AESCAESC is a global leader in battery technology, with...


  • Santa Clara, California, United States Picarro Full time

    Job DescriptionWe are seeking a highly skilled Environmental Compliance Manager to lead our Fenceline Monitoring business, focusing on managing high-priority projects related to regulatory compliance and monitoring plan development for industrial customers.Key Responsibilities:Oversee the proposal development, implementation, and operation of fenceline...


  • Santa Monica, California, United States Larson Maddox Full time

    We are a leading Private Equity Firm seeking a detail-oriented Compliance Generalist to join our dynamic team in the United States.Key ResponsibilitiesConduct comprehensive reviews of marketing materials to ensure compliance with regulatory requirements and internal policies, utilizing your strong analytical skills.Assist in the preparation and submission of...


  • Santa Clara, California, United States CoreSite Full time

    Job OverviewWe are seeking a highly skilled Data Center Operations Expert to join our team at CoreSite. This is an exciting opportunity for a seasoned professional to leverage their expertise in electrical and mechanical systems to ensure the operational integrity and regulatory compliance of our facilities and data center.


  • Santa Clara, California, United States Apollo Professional Solutions Full time

    Job OverviewApollo Professional Solutions, Inc. is seeking a skilled Global Training and Compliance Process Specialist to join our team. This hybrid position is located in Branchburg, NJ and is ideal for local candidates.In this role, you will be a key member of the Global Q&R Compliance Training Chapter, responsible for developing and implementing training...