Principal Regulatory Compliance Specialist

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:
Legal & Compliance

Job Sub Function:
Enterprise Compliance

Job Category:
Professional

All Job Posting Locations:
San Jose, California, United States of America

Job Description:

Johnson & Johnson Medical Devices a member of the Johnson & Johnson Family of Companies is recruiting for a Principal Regulatory Compliance Specialist! This position will be located in San Jose, California.

Position Summary:

Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-speciality, end-to-end solutions in orthopaedics, endoluminal intervention and general surgery.

This includes the MONARCH® platform, a first-of-its-kind robotic technology indicated for bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures in the lung.

Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures.

Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives.

Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact.

For more information, visit www.ethicon.com.


* This position is expected to provide key oversight and support for Regulatory Compliance and Outreach for the Supply Chain.


* This position will be a member of the Sector Regulatory Compliance team within the JJRC organization and will work closely with the Business/Franchise and Supply Chain compliance as site compliance.


* This position will support and enable strong coordination of compliance activities between businesses/franchises, operating companies and sites.

Key Responsibilities:


* External inspection readiness and associated activities.  Lead and manage site audit readiness activities to ensure inspection readiness at all time


* Prepare and host (as required) external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site.

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