Sr. Manager, Regulatory Compliance - Shockwave Medical

Company: Johnson & Johnson
Location: Santa Clara
Posted on: May 3, 2025

Job Description:

At 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 .
Job Function:
Procurement
Job Sub Function:
Category
Job Category:
Professional
All Job Posting Locations:
Santa Clara, California, United States of America
Job Description:
Johnson & Johnson is hiring for a Sr. Manager, Regulatory Compliance - Shockwave Medical to join our team located in Santa Clara, CA.
At 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 .
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. We're pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for treating atherosclerotic cardiovascular disease using proprietary sonic pressure waves for calcified plaque treatment.
Job Summary
The Regulatory Compliance Senior Manager provides strategic oversight for all Regulatory Compliance areas in Shockwave worldwide, partnering with leaders across R&D, Regulatory Affairs, Quality, Legal, Supply Chain, Clinical, and Johnson & Johnson Regulatory Compliance to manage risk and ensure compliance. Responsibilities include inspection readiness, audit programs, remediation support, and integration of new products and acquisitions. Acts as a delegate to the Sr. Director of Regulatory Compliance as needed.
Responsibilities

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• Ensure compliance with standards, regulations, and internal policies, implementing strategies aligned with MDQ&C and JJRC.
  
• Lead governance and processes to meet compliance goals, providing innovative solutions for cross-functional issues.
  
• Participate as a member of the J&J MD Regulatory Compliance Leadership Team and other leadership teams as delegated.
  
• Manage internal and external relationships, develop and oversee the compliance budget, and ensure effective internal audits.
  
• Support site inspection readiness, develop corrective action plans, and monitor their implementation.
  
• Lead external inspection preparations, including HA inspections, MDSAP, and notified body audits.
  
• Collaborate with stakeholders to identify and address compliance issues, support remediation and response to health authority observations.
  
• Support workforce development through the Internal Compliance Academy and facilitate integration of acquisitions into quality systems.
  
• Provide data analytics and insights on compliance trends and risks, advise on new products and acquisitions, and lead continuous improvement initiatives.
  
• Ensure adherence to health, safety, and environmental policies, and perform other duties as assigned.
  
  Experience & Education
  
  • 
    
  • 10+ years in a regulated industry with a bachelor's degree.
    
  • Deep knowledge of cGMPs/QSR, ISO13485, EUMDR, MDSAP, and international regulations.
    
  • Strong communication, leadership, and project management skills.
    
  • Proven ability to influence, negotiate, and manage complex projects and teams.
    
    Skills & Certifications
    
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    • Experience managing health authority inspections, internal audits, and expertise in ISO 13485, EUMDR, FDA CFR 820.
      
    • Preferred certifications: Certified Quality Auditor, Green Belt, or Project Management certifications.
      
    • Excellent communication, problem-solving, and leadership skills.
      
      Compensation & Benefits
      The salary range is $138,000 - $238,050, with performance-based bonuses, comprehensive benefits, retirement plans, and time-off policies. Additional details are available at .
      Johnson & Johnson is an Equal Opportunity Employer, committed to inclusion and diversity. Accommodations are available for applicants with disabilities upon request.
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