Sr. Regulatory Operations Specialist - Shockwave Medical
Company: Disability Solutions
Location: Santa Clara
Posted on: February 8, 2025
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Job Description:
Johnson & Johnson is hiring for a Sr. Regulatory Operations
Specialist - Shockwave Medical to join our team.\rAt Johnson &
Johnson, we believe health is everything. Our strength in
healthcare innovation empowers us to build a world where complex
diseases are prevented, treated, and cured, where treatments are
smarter and less invasive, and solutions are personal. Through our
expertise in Innovative Medicine and MedTech, we are uniquely
positioned to innovate across the full spectrum of healthcare
solutions today to deliver the breakthroughs of tomorrow, and
profoundly impact health for humanity. Learn more at
https://www.jnj.com/.\rFor more than 130 years, diversity, equity &
inclusion (DEI) has been a part of our cultural fabric at Johnson &
Johnson and woven into how we do business every day. Rooted in Our
Credo, the values of DEI fuel our pursuit to create a healthier,
more equitable world. Our diverse workforce and culture of
belonging accelerate innovation to solve the world's most pressing
healthcare challenges. We know that the success of our business -
and our ability to deliver meaningful solutions - depends on how
well we understand and meet the diverse needs of the communities we
serve. Which is why we foster a culture of inclusion and belonging
where all perspectives, abilities and experiences are valued and
our people can reach their potential.\rAt Johnson & Johnson, we all
belong.\rShockwave Medical, Inc., recently acquired by Johnson &
Johnson, 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.\rPosition OverviewThe Senior Regulatory
Operations 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. Works closely and partners with
Regulatory colleagues and other internal departments to meet
assigned deliverables and identify areas of improvement within
Regulatory Operations efficiently and effectively. The function of
the Senior Regulatory Affairs Specialist, Operations, includes
providing submission publishing/verification support and Regulatory
compliance support. Under direction of responsible Regulatory
Affairs Management, works independently with minimal
oversight.\rEssential Job Functions
Keywords: Disability Solutions, Santa Clara , Sr. Regulatory Operations Specialist - Shockwave Medical, Healthcare , Santa Clara, California
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