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*staff regulatory compliance engineer*-*2306112516w*descripción*at *johnson & johnson*,* the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.diversity & inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.
regardless of your race, belief, sexual orientation, religion, or any other trait, you are welcome in all open positions at the largest healthcare company in the world.when you join johnson & johnson, your move could mean our next breakthrough.at johnson & johnson medical devices companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.in a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.we are in this for life.we are changing the trajectory of human health, *you can too*.
*we are searching for the best talent for staff regulatory compliance engineer to be in juárez*purpose*:the regulatory compliance engineer, under the supervision of the regulatory compliance manager, is responsible for maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and j&j corporate requirements*you will be responsible for*:responsibilities may include, but are not limited to:*1.
external audit/inspection readiness and management.*a.
support external audit/inspection readiness activities to ensure site readiness at all times including audit logistics, from room/back room arrangements, identifying/preparing sme's, etc.b.
support external audits/inspections of the sitee.g.
notified body, health authority, ministry of health, fda, regulatory agency, or jjrc/erc.c.
as required, assess the risk and applicability of external audit/inspection observations from other j&j facilities to determine impact to the site.d.
support mock external audits/inspections as part of external audit/inspection readiness activities.e.
provide timely information to support the external audit/inspection process.f.
provide guidance to prepare responses to any regulatory agency notification or correspondence associated with the site.g.
provide guidance to ensure timely and adequate responses to external audit/inspection observations related to the site, including failure investigations, root cause analysis, risk assessments, correction, corrective and preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure.h