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 guide...