Job Title:
Sr. Regulatory Operations Specialist (Remote) - Shockwave
Company Name:
Johnson & Johnson MedTech
Location:
Santa Clara, California, United States (Remote available)
Date Posted:
2025-04-25
Requisition Number:
2506238102W
Work Pattern:
Fully Remote
Application Deadline:
2025-05-16 (may be extended)
Function:
Regulatory Affairs Group
Sub Function:
Regulatory Affairs
Job Category:
Experienced Analyst, Regulatory Affairs (P5)
Employment Type:
Full-time
Job Description:
Johnson & Johnson is hiring for a Senior Regulatory Operations Specialist to join the Shockwave Medical team. This role supports securing and retaining global regulatory approvals for medical devices, specifically Intravascular Lithotripsy (IVL) products. The position is remote within the United States or based in Santa Clara, CA.
Key Responsibilities:
Publisher for worldwide regulatory submissions in compliance with geography-specific regulatory requirements
Verify and qualify review of submissions and responses to regulatory agencies
Archive correspondence and track licenses/registrations
Ensure regulatory compliance with UDI and other standards
Manage regulatory operations, policies, and SOPs
Support audit activities and regulatory communications
Provide support for product recalls and import/export requirements
Assist in process improvement projects and documentation
Write and edit technical documents as needed
Qualifications:
Bachelor's degree in science, math, engineering, or related field
Minimum 5 years of experience in regulatory affairs within healthcare or equivalent
Proficient with MS Word, SharePoint, Excel, Adobe, and PowerPoint
Familiar with regulatory systems like CECATS, FDA Establishment Registration, eSubmitter, and EUDAMED
Strong communication and project management skills
Organized, detail-oriented, and able to manage multiple tasks concurrently
Compensation:
Base Salary (Outside Bay Area): $89,000 – $143,750
Base Salary (Bay Area): $103,000 – $165,600
Eligible for annual performance-based cash bonuses
Long-term incentive programs
Benefits:
Medical, dental, vision insurance
Life insurance, short- and long-term disability
Group legal and accident insurance
401(k) savings and pension plans
Vacation: up to 120 hours/year
Sick leave: up to 40–56 hours/year
Holidays: up to 13 days/year
Personal and family time: up to 40 hours/year
For more information: Employee Benefits
EEO Statement:
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
Disability Accommodation:
For accommodation requests, contact: ra-employeehealthsup@its.jnj.com
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