Regulatory Affairs Specialist

1 semana atrás

São Paulo, São Paulo, Brasil Edwards Lifesciences Tempo inteiro

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives.

How you ́ll make an impact

Completes and maintains regulatory approvals and clearances of assigned products. Create regulatory submissions/playbook, exercising judgment to protect proprietary information) for finalization and submission; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize regulatory activities with operating plans as well as ensuring alignment in assigned countries/area of work (e.g., country clusters, COE, Canada) Identify and develop moderately complex Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards including executing all RA activites in Edwards systems to ensure compliant product distribution. Identify trends, assess impact, analyze alternatives and recommend action plans Participate in representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, and resolving conflicts between those requirements and development issues, and/or reporting to management. Participate in providing guidance and feedback to stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirement) including assessing impact to appropriate regulations Prepare documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies Review and approve materials (e.g., collateral) from cross-functional teams Incidental: Other duties as assigned by Management

What you will need

Bachelor's Degree in related field, 3 years experience previous related experience Required in scientific discipline (e.g., Biology, Microbiology, Chemistry) Preferred Other: Coursework, seminars, and/or other formal government and/or trade association training Preferred Experience in preparing domestic and international product submissions Advanced Portuguese and Spanish Intermediate English Knowledge of Brazilian regulation Knowledge of other regulations in the region

What else will help you

Good medical writing skills Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel Good problem-solving, decision-making, organizational, analytical and critical thinking skills Good written and verbal communication skills and interpersonal relationship skills Ability to read, write and speak English required; Fluency in other language (e.g., German, French, Spanish, Italian, Portuguese, Russian, Polish) preferred Solid knowledge and understanding of global regulations relevant to medical devices (e.g., Class I, Class II and/or Class III devices) Solid knowledge and understanding of global regulatory requirements for new products or product changes. Solid knowledge of new product development systems Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

  • regulatory affairs junior specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Kenvue Tempo inteiro

    REGULATORY AFFAIRS JUNIOR SPECIALIST W Description Kenvue is currently recruiting for: Latam CMC Regulatory Affairs Jr Specialist This position reports to Latam CMC Regulatory Affairs Manager and is based at São Paulo. Who we are At , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science,...

  • Regulatory Affairs Junior Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Kenvue Inc Tempo inteiro

    Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. Job Description - REGULATORY AFFAIRS JUNIOR SPECIALIST W) REGULATORY AFFAIRS JUNIOR SPECIALIST W Description Kenvue is currently recruiting for: Latam CMC Regulatory Affairs Jr Specialist This position reports to Latam CMC Regulatory...

  • Regulatory Affairs Junior Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil J&J Brazil Tempo inteiro

    Kenvue is currently recruiting for: Latam CMC Regulatory Affairs Jr Specialist This position reports to Latam CMC Regulatory Affairs Manager and is based at São Paulo .Who we are At Kenvue , we realize the extraordinary power of everyday care.Built on over a century of heritage and rooted in science, we're the house of iconic brands - including Neutrogena,...

  • Regulatory Affairs Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Edwards Lifesciences Tempo inteiro

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail...

  • regulatory affairs specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Kenvue Tempo inteiro

    REGULATORY AFFAIRS SPECIALIST W Description Kenvue is currently recruiting for: Regulatory Information Management (RIM) Specialist This position reports into Manager, Global Reg Strategic Compliance and is based at Brazil.- São Paulo Capital. Who we are At , we realize the extraordinary power of everyday care. Built on over a century of heritage...

  • Senior Reg Affairs Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Regulatory Affairs Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiro

    We are searching for the best talent for Regulatory Affrairs Specialist to be in São Paulo.In this role the main responsabilities are: Ensure registration pipeline/changes and renewals program submission is done in timely manner Participate in teams to execute regulatory strategic plans with some guidance. Prepare and submit proper regulatory documents and...

  • Senior Regulatory Affairs Specialist

    Há 7 dias

    São Paulo, São Paulo, Brasil The BIG Jobsite Tempo inteiro

    Product Steward who have the overall coordination to manage product stewardship reviews (e.G GHS regulations), existing and emerging regulations, labelling and other requirements which comprehends Latin America region. These activities may include the development of safety data sheets and cross functional trainings;Ensure company operatesin conformity with...

  • Sr. Regulatory Affairs Analyst

    1 semana atrás

    São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiro

    Sr. Regulatory Affairs Analyst W Description Kenvue is currently recruiting for: Specialist Sr, Regulatory Affairs This position reports to LATAM CMC Regulatory Affairs Manager and is based at Sao Paulo. Who we are At , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house...

  • Regulatory Affairs Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Kenvue Tempo inteiro

    Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. Job Description - Regulatory Data Specialist W) Regulatory Data Specialist W Description Kenvue is currently recruiting for: Regulatory Information Management (RIM) Specialist This position reports into Manager, Global Reg Strategic...

  • Regulatory Affairs Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Stryker Tempo inteiro

    What We Want- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.- Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.- Analytical problem solvers....

  • Regulatory Affairs Consultant

    1 semana atrás

    São Paulo, São Paulo, Brasil Parexel Tempo inteiro

    Skills and knowledge:Regulatory Affairs Consultant should have solid local expertise in submitting Clinical Trials to Health Authority in Brazil.This role will be responsible for managing and coordinating the regulatory submission strategy for a large number of clinical trials in Brazil. Also, will coordinate and manage flow of information, track project...

  • Sr. Regulatory Affairs Analyst

    1 semana atrás

    São Paulo, São Paulo, Brasil Bristol Myers Squibb Tempo inteiro

    Working with UsChallenging. Meaningful. Life-changing. Those words aren't commonly associated with a job. But at Bristol Myers Squibb, things are far from ordinary. Here, every department experiences unique and interesting work daily. From optimizing production lines to groundbreaking advancements in cell therapy, the work done here positively impacts...

  • Regulatory Affairs Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Johnson & Johnson Consumer Inc Tempo inteiro

    Kenvue is currently recruiting for: Regulatory Information Management (RIM) Specialist This position reports into Manager, Global Reg Strategic Compliance and is based at Brazil.- São Paulo Capital.Who we are At Kenvue , we realize the extraordinary power of everyday care.Built on over a century of heritage and rooted in science, we're the house of iconic...

  • Regulatory Affairs Manager

    2 meses atrás

    São Paulo, São Paulo, Brasil Abbott Laboratories Tempo inteiro

    About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will...

  • Regulatory Affairs Manager

    3 semanas atrás

    São Paulo, São Paulo, Brasil Abbott Laboratories Tempo inteiro

    About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will...

  • Sr. Regulatory Affairs Analyst

    1 semana atrás

    São José dos Campos, São Paulo, Brasil J&J Brazil Tempo inteiro

    Kenvue is currently recruiting for: Specialist Sr, Regulatory Affairs This position reports to LATAM CMC Regulatory Affairs Manager and is based at Sao Paulo.Who we are At Kenvue , we realize the extraordinary power of everyday care.Built on over a century of heritage and rooted in science, we're the house of iconic brands - including Neutrogena, Aveeno,...

  • Senior Regulatory Affairs Specialist

    2 semanas atrás

    São Paulo, São Paulo, Estado de São Paulo, Brasil Tata Consultancy Services Tempo inteiro

    Come to one of the biggest IT Services companies in the world!! Here you can transform your career! Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools,...

  • Regulatory Affairs Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Caldic LATAM Tempo inteiro

    Responsabilidades e atribuições Coordinate and request technical information (GMO, Prop 65, Etc.) from suppliers Create/maintain product specifications for ingredients, resale and manufactured products Backup for ticket assignment/triage. Maintenance of Portal documentation/connections Maintain SpecSafe contacts Other tasks as assignedRequisitos e...

  • Senior Regulatory Affairs Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Tata Consultancy Services Tempo inteiro

    Come to one of the biggest IT Services companies in the world Here you can transform your career Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to...