Regulatory Affairs Specialist

3 semanas atrás

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

    Há 5 dias

    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

    Há 5 dias

    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

    Há 5 dias

    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

    Há 5 dias

    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

    Há 5 dias

    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...

  • Regulatory Affairs Specialist

    Há 5 dias

    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...

  • Regulatory Affairs Specialist

    2 semanas atrás

    Sao 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...

  • Senior Reg Affairs Specialist

    Há 5 dias

    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

    2 semanas atrás

    Sao Paulo, Brasil Johnson & Johnson Tempo inteiro

    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 Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science,...

  • Regulatory Affairs Analyst

    Há 7 dias

    Sao Paulo, Brasil MSD Tempo inteiro

    **Job Description**: **SUMMARY** The Associate Specialist, Regulatory Affairs supports a variety of regulatory and cross-functional initiatives and executes/ tracks all activities associated to different types of regulatory submissions and products, in collaboration with internal and external stakeholders, following global and local strategies and oriented...

  • Regulatory Affairs Specialist

    Há 5 dias

    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 5 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...

  • Senior Reg Affairs Specialist

    3 semanas atrás

    Sao 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...

  • Senior Reg Affairs Specialist

    Há 7 dias

    Sao 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...

  • Sr. Regulatory Affairs Analyst

    Há 5 dias

    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

    Há 5 dias

    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 Manager

    2 semanas atrás

    Sao Paulo, Brasil Unilever Tempo inteiro

    **Unilever is currently hiring for a Regulatory Affairs Manager based in São Paulo.** **Unilever** is the place where you can bring your purpose to life with the work that you do - creating a better business and a better world. We are looking for talents that would like to join this exciting journey with us. Our **R&D Brazil Beauty & Wellbeing** team is...

  • Regulatory Affairs Specialist

    Há 5 dias

    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

    Há 5 dias

    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

    Há 6 dias

    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...