📌 Position Title:
Manager, Regulatory Affairs – Shockwave Medical
🏢 Company:
Johnson & Johnson – Shockwave Medical
🔗 Learn More About J&J
🔗 Careers at J&J
🌍 Location:
Work Pattern: Fully Remote (U.S. based only)
Primary Location (HQ): Santa Clara, California, USA
Requisition Number: R-030737
Date Posted: September 2, 2025
Application Deadline: Not specified
🧭 Position Summary:
The Manager, Regulatory Affairs for Shockwave Medical will lead regulatory strategy and execution across U.S. and global markets for the company’s intravascular lithotripsy (IVL) products. This position will support the development, manufacturing, and distribution of Class III medical devices by ensuring compliance with evolving regulatory requirements while enabling timely product submissions and approvals.
You will be a key contributor to the global strategy and a mentor to team members, playing a hands-on role in developing the next generation of smart, minimally invasive cardiovascular technologies.
💼 Job Function:
Function: Regulatory Affairs
Sub-function: Regulatory Affairs
Category: Manager, Regulatory Affairs (PL7)
Level: People Leader
🧠 Key Responsibilities:
🔹 Regulatory Strategy & Compliance
Develop, maintain, and communicate regulatory strategies aligned with product and business goals.
Monitor regulatory trends and proactively adapt strategies to changes in U.S. and international requirements.
Interpret and apply regulatory requirements to ensure global compliance.
🔹 Submissions & Documentation
Lead preparation of regulatory submissions including 510(k), IDE, PMA, EU Technical Files, and Design Dossiers.
Review and approve preclinical, clinical, quality, and engineering documentation for regulatory use.
Manage import/export regulations, product registrations, and annual renewals across geographies.
🔹 Regulatory Operations
Interact and negotiate directly with global regulatory agencies during submission and review processes.
Ensure timely communication of submission status and progress with stakeholders.
Lead and manage direct reports and support their professional development.
🔹 Cross-functional Collaboration
Provide regulatory input to R&D, quality, marketing, and manufacturing teams.
Evaluate the impact of design, clinical, and manufacturing changes on regulatory status.
Participate in recall, vigilance, and safety reporting (e.g., MDR) processes when applicable.
🔹 Compliance & SOPs
Develop and maintain SOPs, work instructions, and regulatory policies.
Train internal stakeholders on regulatory procedures and expectations.
Ensure compliance with relevant ISO, IEC, REACH, ROHS, and 21 CFR standards.
🔹 Advertising & Promotion Review
Approve marketing, advertising, and promotional materials to ensure regulatory compliance.
🎓 Qualifications:
📘 Education:
Required: Bachelor’s degree in science, engineering, math, medical, or technical field
Preferred: Master’s degree or Ph.D. in a related field
🧠 Experience:
10+ years of regulatory experience with a Bachelor’s degree
8+ years with a Master’s degree
4+ years with a Ph.D.
Experience in the regulated healthcare industry, ideally with Class III medical devices
Medical device software or software engineering experience is a plus
✅ Key Competencies:
Deep knowledge of U.S. and international regulatory pathways and standards
Experience with full lifecycle regulatory submissions (e.g., 510(k), PMA, IDE, EU MDR)
Strong analytical and strategic thinking skills
Clear and effective written and verbal communication with internal teams and external agencies
Leadership and mentoring capabilities
Strong project management and multi-tasking abilities in a fast-paced environment
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)
🏆 Compensation & Benefits:
💰 Anticipated Base Pay Range (U.S.):
Standard U.S. range: $115,000 – $197,000
Bay Area range: $141,000 – $227,700
🎁 Benefits (Eligibility based on plan terms):
Medical, dental, and vision insurance
Life insurance, short/long-term disability
Business accident and group legal insurance
Retirement programs: Pension plan and 401(k)
Long-term incentive program
🕒 Time Off:
Vacation: 120 hours/year
Sick Time: 40 hours/year (56 hours in Washington state)
Holidays: 13 days/year (including floating holidays)
Personal & Family Time: 40 hours/year
Parental Leave: 480 hours within 12 months of qualifying event
Additional leave options:
Condolence Leave (30 days for immediate family)
Caregiver Leave (10 days)
Volunteer Leave (4 days)
Military Spouse Time-Off (80 hours)
📄 More details: J&J Employee Benefits
🌍 Inclusion & Accessibility:
Johnson & Johnson is committed to diversity, equity, and inclusion. We welcome and encourage applications from:
Veterans
Individuals with disabilities
Candidates of all races, ethnicities, genders, and identities
📧 Accommodation Requests:
Email: Contact Us
Or contact AskGS for assistance
⚖️ Equal Opportunity 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, age, national origin, disability, or protected veteran status.
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