Staff Regulatory Compliance Engineer - Ciudad Juarez, México - Johnson & Johnson

Johnson & Johnson

Empresa verificada

Ciudad Juarez, México

hace 3 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

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 RegulatoryCompliance Engineer, under the supervision of the RegulatoryCompliance Manager, is responsible formaintaining 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/inspectionreadiness and management.
a.

Support external audit/inspectionreadiness 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/inspectionsof 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/inspectionobservations 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/inspectionobservations 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. Ensure timely and accurate reporting and publishing of externalaudit metrics. Drive compliance and improvements in metrics targets.

2. Internal Audit Program and Management Execution
a. Execute internal audits according to the established internal audit procedures.

b. Ensure internal audit results are reported to management having responsibility for the matters audited.

c. Ensure timely and adequate responses to internal audit observations, 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

d. Ensure timely and accurate reporting and publishing of internal audit metrics. Drive compliance and improvements in metrics targets.

e. Ensure documentation and records related to the internal audit program are maintained.

f.

Ensure all quality system elements/processes applicable to the site are audited and appropriate actions are taken to meet the business and regulatory requirements.

3. Enterprise, Sector and JJRC Support
a. Participate in JJRC audits as requested.

b. Connect and collaborate with the compliance teamsof other sites, regions and business groups.

4. Metrics Collection and Reporting
a.

Assure that internal and external audit metrics are consistently and accurately captured, and that they are reported and published at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain).

b. Drive compliance and improvements in metrics targets.

c. Create reports and communicate performance against metrics to key stakeholders.

d. Highlight/communicate adverse trends in metrics, and take risk based action to remediate.

5. Escalations
a. Escalate quality issuesin accordance with established procedures.

6. External Standards and Regulations
a. Support implementation of new/revised regulations and standardsfor the site.

b. Maintain current knowledge of regulatory changes through indust