Staff Regulatory Compliance Specialist

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.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

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

About 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 STAFF REGULATORY COMPLIANCE SPECIALIST

Purpose:
Conducts audits planned and unplanned to verify compliance with government regulations and applicable standards in addition to company policies and procedures. Give guidance or advice to the organization as it relates to compliance when required.

You will be responsible for:

Under general direction and in accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

• It ensures that Quality System Audits comply with the requirements of QSR/GMP and ISO Standards

• Conducts internal audits of the Quality System for the purpose of verifying compliance with government regulations and applicable standards in addition to company policies and procedures. Conducts good laboratory practice (GLP) audits as required.

• Gives guidance or advice as it relates to compliance with applicable standards and regulations.

• Performs re-audits to deficient aspects and to implement corrective and preventive actions as necessary and required.

• Assigns classifications to internal audit observations and documents audit results in written reports that can be distributed and reviewed by appropriate management.

• Monitors the effectiveness of corrective actions documented in observation responses.

• You can be the lead auditor of a team of auditors technical experts auditors-in-training and/or volunteer auditors.

• Reviews ownership of responses to audit observations also acts as an advisor to other areas that are not being audited by him/her giving advice on audit observation responses.

• Maintains audit report files re-audit files and responses to audits carried out.

• Accompanies external auditors representatives of government agencies or those required by management during the execution of an applicable audit.

• Conducts audits at other J&J sites when required by management.

• Complies with and reviews compliance metrics and communicates them to site management and the Franchise. Prepares information for Management review boards.

• Participates in the formulation of Regulatory Policies and Procedures in compliance with applicable local state and federal standards and regulations through the development of Franchise Documents.

• It is kept up to date on government regulations and applicable standard changes through publications participation in seminars or by collaboration with organizations.

• 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

• Performs other duties assigned as needed

Qualifications / Requirements:

• BS in science engineering or business.

• MBA or Masters in Science preferably.

• Minimum 6 years of experience in Quality Regulatory Compliance or related activities

• Experience in Medical Devices field or in Pharmaceuticals (preferably).

• Effective communication skills oral and written (English and Spanish).

• Analytical skills to interpret scientific and technical publications and legal documents.

• Ability to select manage and lead a team during an audit.

• Ability to respond to questions or complaints from clients regulatory agencies or members of the business community.

• Skills to present information effectively to senior management public groups and/or directors.

• Skills to work with mathematical concepts such as probability and statistical inferences fundamentals of geometry and trigonometry.

• Skills to interpret a variety of instructions presented in writing verbally or graphically (diagrams and programs).

• Skills for the use of computers and associated systems (software).

• Skills to interact with auditors by the government and independents.

• Skills and knowledge of methods and techniques related to quality including audit principles and techniques quality terminology quality management principles and their applications as well as quality management tools and their applications.

• Knowledge in problem-solving techniques.

• Lead auditor certification preferred.

Required Skills:

Preferred Skills: