Sr. Manager, Regulatory Compliance - Shockwave Medical

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. Ready to join a team that’s 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 medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

JOB SUMMARY

The Regulatory Compliance Senior Manager provides key strategic insight, direction, and oversight for all areas of Regulatory Compliance in Shockwave worldwide. Partners with leaders in R&D, Regulatory Affairs, Quality, Legal, Supply Chain, Clinical and Johnson & Johnson Regulatory Compliance to manage risk and ensure a strong regulatory compliance profile. Assures quality and compliance risk is identified and mitigated. Responsible for the Inspection Readiness, Inspection Management, and the Internal Audit program for all 3 (three) Shockwave Sites including Source Compliance. Supports the development and execution of remediation programs as needed. Supports the Integration Plan and New Product Introductions as JJRC member. Can act as a delegate to the Sr. Director Regulatory Compliance.

DUTIES & RESPONSIBILITIES

Under limited supervision, general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Ensures compliance to standards, regulations, and internal policies. Responsible for implementing compliance strategies aligned with the MDQ&C and JJRC strategies.

• Leads processes, organizations, and governance to assure that compliance related requirements and goals for the MD Sites under responsibility are achieved. Provides innovative solutions to cross-functional compliance issues, assuring that the solution falls within appropriate regulatory guidance.

• Can serves as a contributing member of the J&J MD Regulatory Compliance Leadership Team (LT) and an extended member of the Business Q&C LT and JJRC LT as delegated by the Sr. Regulatory Compliance Director.

• Manage relationships internally and externally and build cross-functional/departmental effectiveness.

• Develops and manages the Compliance budget as per the approved Business Plan.

• Ensures that a robust, efficient, and close loop internal audit program is executed per schedule by highly skilled compliance professionals.

• Support the sites in the development of corrective action plans to address observations. Monitor the effective and timely implementation of these corrective action plans.

• Develops and execute external inspection readiness plan for all sites.

• Ensures successful HA inspections, MDSAP certifications, notified body inspections, and readiness/transition for new regulations and standards.

• Partner