Director, Regulatory Compliance

About this role

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Legal & Compliance

Job Sub Function: Enterprise Compliance

Job Category: Professional

All Job Posting Locations: Irvine, California, United States of America

Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Director, Regulatory Compliance, to be located at Irvine, CA.

Purpose: The Director, Regulatory Compliance is responsible for tactical and strategic compliance support to the Johnson and Johnson's regulatory compliance (JJRC) organization. This role provides regulatory compliance expertise and has independent compliance oversight to ensure regulatory standards are met. This role is responsible for leading and executing JJRC follow-up activities related to independent audits such as PAA’s and routine ERC audits, supplier/EM compliance assessments as needed, significant inspections, field actions, and health authority actions, as well as ensuring inspection readiness at high-risk sites. This role is instrumental in helping to identify, escalate, and mitigate risks. 

This position reports solid line to the Sr. Director Regulatory Compliance, within the Johnson and Johnson Regulatory Compliance (JJRC) organization. 

Key Responsibilities: • Responsible for supporting a robust regulatory compliance program for the worldwide headquarters, manufacturing sites, and R&D sites within Cardiovascular Segment of J&J, which includes Electrophysiology (BW), Neurovascular (NV) and Sustainability Solutions (SS). 

• Understands the factors contributing to compliance risk profiles, based on metrics and data analysis and other intelligence (e.g., escalations, regulatory inspection outcomes, etc.), to proactively identify, communicate, prioritize, address/prevent/reduce compliance risk. 

• Conducts Follow-up activities for the JJRC independent audit program, field action assessments, significant health authority inspections, and regulatory actions. The position provides an independent evaluation of compliance events and trends and assures appropriate reporting and escalation commensurate with policy. 

• Provides leadership and expertise to interpret and evaluate audit observations and provides guidance and support to develop risk-based action plans. Identifies opportunities for cross-regional/site remediation activities collaborate with Segment Quality and Compliance professionals to develop risk-minimizing strategies. 

• Support supplier/EM compliance activities through the review of supplier audit reports and follow-up reports. Participate in early engagement activities with stakeholders. Assist with escalation and alignment activities associated with supplier/EM outcomes as needed.  

• Attends RMB, QRB, and franchise management reviews, as required.  

• Provides oversight and compliance review of remediation programs (MCAP/SDCAP/QEP, PAM, etc.).  

• Represents Compliance on JJRC Enterprise Forums and provides input to JJRC independent audit plan. Ensures partnership with JJRC and other Q&C groups to leverage work / resources to minimize duplication.  

• Interprets and communicates current and emerging regulatory and J&J requirements at a global level. Partners with Q&C and Enterprise Regulatory Outreach groups to continuously monitor the changing regulatory climate to proactively assess and communicate industry trends and emerging areas with potential impact to compliance programs.  

• Serve as a key advisor and subject matter expert for critical compliance activities, including due diligence, mock inspections, regulatory agency interactions, decommissioning, divestiture, Quality System and Compliance Analysis (Q-SCAN) execution, special investigations, and business strategies, as needed.  

• Supports Health Authority inspection readiness activities at high risk sites, ensures subject matter expert preparedness, and reviews significant communications with Health Authorities.  

• Engages with high risk sites, as needed, to oversee and, if necessary, verify remediation efforts.   

Qualifications: • A minimum of a BS is required.  A focused degree in science, engineering, or equivalent is highly preferred.

• A minimum of 10 years of progressive experience in the pharmaceutical/medical device/biotech industry.  

• Significant experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment.  

• Expert and broad-based knowledge of Quality System regulations, ISO, ICH, PIC/S, and GMP regulations.  

• Experience performing GXP audits.  

• Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc.  

• Ability to resolve complex regulatory compliance issues.  

• Ability to analyze and interpret scientific and technical journals, and legal documents.  

• Proven success in strategy development and project management, building consensus acr

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