Sr. Manager, Regulatory Compliance - Shockwave Medical

Johnson & Johnson; Santa Clara (CA); On-site; USD 138,000 - 239,000; Full time

Job summary

An established industry player is seeking a Sr. Manager for Regulatory Compliance to oversee compliance across various functions in the innovative field of healthcare. This pivotal role involves ensuring adherence to regulatory standards, managing inspections, and leading cross-functional initiatives to support product development. The ideal candidate will bring over a decade of experience in regulated environments, demonstrating strong leadership and communication skills. Join a forward-thinking team dedicated to pioneering advancements in healthcare solutions and making a significant impact on patient outcomes.

Benefits

Comprehensive benefits

Retirement plans

Performance-based bonuses

Time-off policies

Qualifications

• 10+ years in a regulated industry with a bachelor's degree.
• Deep knowledge of cGMPs/QSR and international regulations.

Responsibilities

• Ensure compliance with standards and internal policies.
• Manage internal and external relationships for compliance.

Skills

Regulatory Compliance

Project Management

Communication Skills

Leadership Skills

Problem-Solving

Education

Bachelor's Degree

Tools

ISO 13485

EUMDR

FDA CFR 820

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 https://www.jnj.com.

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 https://www.jnj.com/.

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

• 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

• 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 https://www.careers.jnj.com/employee-benefits.

Johnson & Johnson is an Equal Opportunity Employer, committed to inclusion and diversity. Accommodations are available for applicants with disabilities upon request.