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    Regulatory Affairs Sr. Specialist - São Paulo, Brasil - Johnson & Johnson

    Johnson & Johnson
    Johnson & Johnson São Paulo, Brasil

    há 2 semanas

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    Descrição
    Job Description - Regulatory Affairs Sr. Specialist - Fixed Term position (7 months W)
    Regulatory Affairs Sr. Specialist - Fixed Term position (7 months W
    Description
    At Johnson & Johnson, we believe health is everything.

    Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

    Through 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 humanity.

    Learn more at .

    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 healthcare company in the world.

    When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.
    We are searching for the best talent for a Regulatory Affairs Sr.

    Specialist - Fixed Term position (7 months) to be located in Sao Paulo, Brazil: You will be responsible for: Sr.

    Specialist in the Regulatory Excellence team within RA Brazil, being responsible for:

    D
    D

    Request and monitoring of documentation for the preparation of dossiers; Support the regional team on product submissions schedules, prioritization, and pipeline management.

    Interaction with other internal areas and government agencies; Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates.

    Support business plans and regulatory needs; Support regional regulatory processes, as needed; Coordinate the maintenance process of INMETRO Certificates; Provide regulatory support for several audits (Certification Bodies, INMETRO, ANVISA, MDSAP, etc); Develop and/or update area procedures; Train the team, as needed.

    Coordinate investigation and actions related to quality problems in applicable systems (Non Conformances and CAPAs related to Reg. Affairs); Coordinates Change Controls; Support the implementation of new regulations.


    Qualifications Qualifications and requirements:

    Education:
    Bachelor's

    Degree Completed Required:
    Experience/Knowledge required: strong previous experience working on Regulatory Affairs for Medical Devices.

    Experience on Quality Management System processes Previous experience on project management Database analysis skills Problem Solver, Effective communication, courageous, Assertiveness and Pragmatism Preferred:

    Other:
    Primary Location Organization 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
    This site is governed solely by applicable U.S. laws and governmental regulations. Please see our. Use of this site constitutes your consent to application of such laws and regulations and to our. Your use of the information on this site is subject to the terms of our.

    You should view thesection and the most recent SEC Filings in thesection in order to receive the most current information made available by Johnson & Johnson Services, any questions or search this site for more information.

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