Job Title:
Sr Regulatory Affairs Specialist (Remote) - Shockwave
Function:
Regulatory Affairs Group
Sub Function:
Regulatory Affairs
Category:
Experienced Analyst, Regulatory Affairs (P5)
Location:
New Brighton / San Diego / San Francisco / Milpitas / South San Francisco / San Jose / Santa Clara / Irvine / Palo Alto / Chicago / Baltimore / Boston / Raleigh / Philadelphia / Seattle / United States of America
Date Posted:
April 25, 2025
Requisition Number:
2406226090W
Work Pattern:
Fully Remote
Closing Date:
May 08, 2025 (May be extended)
Description:
Johnson & Johnson is hiring for a Sr Regulatory Affairs Specialist – Shockwave Medical to join our team located in New Brighton, MN, or Remote US.
The Senior Regulatory Affairs Specialist works closely with internal departments to meet regulatory requirements, focusing on US and Canadian markets. This position supports the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex cardiovascular disease.
Essential Job Functions:
Collaborate with cross-functional teams on regulatory submissions.
Provide regulatory input for product development and compliance.
Review and approve R&D, quality, and clinical documentation.
Submit high-quality regulatory filings to authorities.
Maintain and renew regulatory licenses, registrations, and listings.
Evaluate product design, clinical, and manufacturing changes for regulatory impact.
Support product recalls and communicate with regulatory authorities.
Plan and conduct meetings and manage projects.
Qualifications:
Minimum of 5 years of experience in regulatory affairs in the medical device industry (or equivalent).
Experience with 510(k), IDE, PMA, EU Technical Files, and international filings.
Class III medical device and/or engineering background preferred.
Proficiency in MS Word, Excel, Adobe, and PowerPoint.
Salary Range:
Outside of Bay Area: $89,000–$143,750
Bay Area, California: $103,000–$165,600
Additional Information:
Eligible for annual performance bonus.
Comprehensive benefits package including medical, dental, vision, life insurance, 401(k), vacation, sick time, and holiday pay.
EEO Statement:
Johnson & Johnson is an Equal Opportunity Employer.
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