Job Description - Senior Regulatory Compliance Specialist (2406180663W)
Senior Regulatory Compliance Specialist - 2406180663W
Description
Senior Regulatory Compliance Specialist
At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for 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 Next Move Could Mean Our Next Breakthrough.
COMPANY
Biosense Webster, Inc. is recognized worldwide as a leader in the science behind the diagnosis and treatment of cardiac arrhythmias. Guided by the needs of electrophysiologists and cardiologists, Biosense Webster has pioneered innovative technological advancements for more than 30 years. Some might call this quite a heritage. At Biosense Webster, we say it's just the beginning. For more information, visit www.biosensewebster.com
JOB RESUME
Conductsaudits—plannedandunplanned— toverifycompliancewithgovernmentregulationsandapplicablestandards, in addition to company policies and procedures. Give guidance or advice to the organization as it relates to compliance, when required.
RESPONSIBILITIES
Under general direction and in accordance with all federal, state, and local laws/regulations and procedures and
guidelines of the Johnson & Johnson Corporation, this position:
o Ensures that Quality System Audits comply with the requirements of QSR/GMP and ISO Standards
o 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.
o Gives guidance or advice as it relates to compliance with applicable standards and regulations.
o Performs re-audits to deficient aspects and to implement corrective and preventive actions as necessary and required.
o Assigns classifications to internal audit observations and documents audit results in written reports that can
be distributed and reviewed by appropriate management.
o Monitors the effectiveness of corrective actions documented in observation responses.
o He/She can be the lead auditor of a team of auditors, technical experts, auditors-in-training, and/or
o 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.
o Maintains audit report files, re-audit files and responses to audits carried out.
o Accompanies external auditors, representatives of government agencies or those required by management during the execution of an applicable audit.
o Conducts audits at other J&J sites when required by management.
o Complies with and reviews compliance metrics and communicates them to site management and the
Franchise. Prepares information for Management review boards.
o 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.
o It is kept up to date on government regulations and applicable standard changes through publications,
participation in seminars or by collaboration with organizations.
o Is responsible for communicating business-related matters or opportunities to the next managerial level
o For those who supervise or manage personnel, they are responsible for ensuring that subordinates follow all of the Company's guidelines related to Health, Safety and Environment practices and that all necessary resources to do so are available and in good condition, if applicable.
o Is responsible for ensuring personal and Company compliance with all Federal, State and Local company regulations, policies and procedures
o Performs other assigned tasks as needed
Qualifications
QUALIFICATIONS AND REQUIREMENTS o BS in science, engineering, or business.
o MBA or Master's in Science, preferably.
o Minimum 3 years of experience in Quality, Regulatory Compliance, or related activities and demonstrated performance.
o Experience in Medical Devices field or in Pharmaceuticals (preferably).
o Lead Auditor Certification by an accredited organization preferred.
o Effective communication skills – oral and written – (English and Spanish).
o Analytical skills to interpret scientific and technical publications and legal documents.
o Ability to select, manage and lead a team during an audit.
o Ability to respond to questions or complaints from clients, regulatory agencies or members of the
business community.
o Skills to present information effectively to senior management, public groups and/or directors.
o Skills to work with mathematical concepts, such as probability and statistical inferences,
fundamentals of geometry and trigonometry.
o Skills to interpret a variety of instructions presented in writing, verbally or graphically (diagrams
and programs).
o Skills for the use of computers and associated systems (software).
o Skills to interact with auditors by the government and independents.
o 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.
o Knowledge in problem-solving techniques.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.andEqual Employment Opportunity Posters GINA Supplement.
If you are an individual with a disability, please check ourpage for information on how to request an accommodation.Disability Assistance
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