Senior Regulatory Compliance Specialist

hace 2 semanas

Juárez, Chihuahua, México Johnson & Johnson A tiempo completo
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

JOB RESUME

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.

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:

  • 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 reaudits 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.
  • He/She can be the lead auditor of a team of auditors, technical experts, auditorsintraining, 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, reaudit 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.

  • Is responsible for communicating businessrelated matters or opportunities to the next managerial level
  • 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.
  • Is responsible for ensuring personal and Company compliance with all Federal, State and Local company regulations, policies and procedures
  • Performs other assigned tasks as needed

Qualifications:

QUALIFICATIONS AND REQUIREMENTS

  • BS in science, engineering, or business.
  • MBA or Master's in Science, preferably.
  • Minimum 3 years of experience in Quality, Regulatory Compliance, or related activities and demonstrated performance.
  • Experience in Medical Devices field or in Pharmaceuticals (preferably).
  • Lead Auditor Certification by an accredited organization preferred.
  • 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

  • Senior Regulatory Compliance Specialist

    hace 2 semanas

    Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

    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...

  • Principal Regulatory Compliance Specialist

    hace 2 semanas

    Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

    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...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Juárez, Chihuahua, México BEPC Inc A tiempo completo

    Regulatory Affairs Specialist Develop and maintain regulatory strategies for the development, registration, and commercialization of medical devices:Communicate with regulatory authorities to obtain timely approvals for medical devices Review and approve labeling, marketing, and promotional materials to ensure compliance with regulations Monitor regulatory...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Juárez, Chihuahua, México BEPC Inc A tiempo completo

    Develop and maintain regulatory strategies for the development, registration, and commercialization of medical devices Communicate with regulatory authorities to obtain timely approvals for medical devices Review and approve labeling, marketing, and promotional materials to ensure compliance with regulations Monitor regulatory changes and provide guidance to...

  • Senior Trade Compliance Analyst

    hace 2 semanas

    Juárez, Chihuahua, México Eaton A tiempo completo

    Eaton's ES CRDS COMM Commercial division is currently seeking a Senior Trade Compliance Analyst.What you'll do:PRIMARY FUNCTION:The Customs Analyst is responsible for providing direct support to Customs Supervisor, to ensure temporary inventory and import/export activity meet with all Mexican Customs regulations for the site, including material, information,...

  • Regulatory Affairs Specialist for Best Medical

    hace 2 semanas

    Juárez, Chihuahua, México BEPC Inc A tiempo completo

    BEPC is looking for:Regulatory Affairs SpecialistRequirements: Bachelor's degree in a scientific discipline 3+ years of experience in Regulatory Affairs in the Medical Device industry Strong understanding of US and international regulations related to medical devices, including FDA, EU MDR, and other global regulations. Experience preparing and submitting...

  • Compliance Manager

    hace 2 semanas

    Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

    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...

  • Compliance Manager

    hace 2 semanas

    Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

    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...

  • Compliance Manager

    hace 2 semanas

    Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

    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...

  • Compliance Engineer

    hace 2 semanas

    Juárez, Chihuahua, México Xylem A tiempo completo

    We're Hiring for a Compliance EngineerIf you are excited and passionate about helping #LetsSolveWater, consider joining our team today Xylem, Inc. is a leading global water technology company servicing more than 150 countries and is dedicated to solving the world's most challenging water issues. We are looking for individuals to join our mission by exceeding...

  • Customs and Trade Compliance

    hace 2 semanas

    Juárez, Chihuahua, México TECMA A tiempo completo

    Trade compliance specialist is responsible and accountable for implementation of trade compliance regulations and policies globally. Trade compliance specialist has an authority to approve or hold export/import transactions, and block transactions, that are not in compliance with global or local trade compliance laws, regulations or policiesDuties and...

  • Anti-fraud and Compliance Sr. Manager

    hace 2 semanas

    Juárez, Chihuahua, México HAT Talent Search A tiempo completo

    Anti-Fraud (Forensic) and Compliance Sr. Manager.Remote Position - Frequent traveling (Domestic and International)Corporate with manufacturing plants in several locations in Mexico is searching an Anti-Fraud (Forensic) and Compliance Sr. Manager. This role focuses on conducting detailed investigations into fraudulent activities, compliance breaches, and...

  • Senior Scientist

    hace 2 semanas

    Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

    Senior Sterility Assurance ScientistAt 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...

  • Senior Engineer

    hace 2 semanas

    Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the world's largest healthcare company, we are united by a common goal: to revolutionize the landscape of global health.Diversity & Inclusion are fundamental in our journey of innovation and excellence, impacting over a billion individuals daily for more than a century. Regardless of your background, beliefs, or identity, every...

  • Coordinador Central de Documentacion

    hace 2 semanas

    Juárez, Chihuahua, México Cardinal Health A tiempo completo

    _What Quality Compliance contributes to Cardinal Health_Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.Quality Compliance is responsible for the development and deployment of policies, procedures and programs designed to minimize risk, enable...

  • Customs Compliance Coordinator

    hace 2 semanas

    Juárez, Chihuahua, México Shelf Company No. 74 A tiempo completo

    RESPONSIBILITIES AND DUTIES: Implementation of new regulations and regulatory changes Preparation of INEGI report Preparation of return reports for Annex 30 Preparation of the Annual Prosec and IMMEX Operations Report. Management and control of Inventories in accordance with Annex 2 Keep costs, BOM's, % of losses and waste, added value, etc. updated in the...

  • Senior Calibration Technician

    hace 2 semanas

    Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

    Diversity, Equity & 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...

  • Senior Engineer, Occupational Safety

    hace 2 semanas

    Juárez, Chihuahua, México Ford Motor Company A tiempo completo

    Education: Bachelor's Degree or Master's Degree (preferred) in Occupational Health & Safety, Safety/Health Sciences, or any other related discipline.Experience: Minimum 1 year of occupational safety work experience with a Master's degree or 2 years of work experience with a Bachelor's degree, preferably in Health and Safety, Occupational Safety, or a related...

  • Procurement Specialist

    hace 2 semanas

    Juárez, Chihuahua, México Ambu A tiempo completo

    Business Area: Employment type: FulltimeA global job position with an impactIn the job as Procurement Specialist you will have the opportunity to support to the organization by meeting the challenging goal of finding new suppliers for the products we make in Mexico, impact product development and your own daily tasks and responsibilities and experience a...

  • Senior Process Engineer

    hace 2 semanas

    Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

    Diversity, Equity & 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...