Senior Regulatory Compliance Analyst

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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About MedTech

Fueled by innovation at the intersection of biology and technology were 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 Electrophysiology

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

As Johnson & Johnson MedTech Electrophysiology we have one goal to ensure those with atrial fibrillation can live the lives they want. For more than 30 years weve been the global market leader in the science and technology of cardiac arrythmia treatment. Our suite of tools means electrophysiologists are empowered to personalize their approaches for patients with effective and reproducible workflows. Together were changing what it means to be diagnosed with atrial fibrillation or other cardiac arrhythmias.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for SENIOR REGULATORY COMPLIANCE SPECIALIST

Purpose:

Under supervision supports monitoring of Compliance Metrics and dashboard maintenance for different forums. Also supports Site Internal Audit Program and External Audit Readiness activities as required.

You will be responsible for:

In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

• Supports monitoring of Compliance Metrics and dashboard maintenance to be presented in different forums.

• Supports the Site Audit Readiness Program as required.

• Support Compliance training education programs applicable to the organization.

• Ensure compliance with the Quality Policy in all activities.

• Interacts with all Department and provides support to company activities as required.

• Provides periodic reports completes special assignments as assigned.

• Creates procedure/document changes and performs implementation tasks as applicable.

• Supports and promotes the safety and industrial hygiene objectives of the plant.

• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures.

• Performs a variety of other duties of a complexity commensurate with the Job Level as assigned or required.

• Follow compliance regulations and standards applicable to the organization.

• Knowledge of Operating Procedures and related computer systems required.

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.

• For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable

• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures

• Provides support on assignments such as developing executive-level presentations for different forums with high visual content based on Quality Systems data.

• Analyzes data and trends.

• Provides general consultancy on the access and use of Audit Module System.

• Supports monitoring of Compliance Metrics and dashboard maintenance to be presented in different forums.

• Executes periodic reports and maintains the required databases to track the progress on the action plans and effectiveness monitoring plans raised from audit observations.

• Supports the readiness activities for external audits as required.

• Supports Compliance training education programs applicable to the organization as required.

• Supports Site Internal Audit Program participating in internal audits.

• Performs other duties assigned as needed

Qualifications / Requirements:

• High school or technical career. Preferably Graduated from an Engineering degree.

• From 2 to 4 years of experience If bachelor degree completed no experience required.

• Experience working in FDA regulated environment (desirable)

• Good written and oral communication skills as well as report writing presentation and training skills both in English and Spanish.

• Computer Literate as Microsoft Office or similar.

• Accomplish objectives in a timely manner with limited day to day supervision.

• Good interpersonal skills; customer service oriented.

• Working Knowledge in Current Good Manufacturing Practices Data integrity and all applicable Standard and Regulations and respective requirements applicable for the organization (preferred)

• Experience as Quality Systems Auditor (preferred).

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