Regulatory Affairs Specialist

6 meses 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 and technical mastery will help ensure our products reach clinicians and improve patients’ lives.
How you´ll make an impact

To ensure patients have access to innovative, high quality, safe and effective solutions to hemodynamic monitoring by obtaining Health Agency Medical Device approvals in compliance with local regulation Standards by being responsible of Regulatory Affairs activities within the respective country(ies).

Create regulatory submissions, 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, Center of Excellence)

Prepare documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies.

Identify and develop moderately complex Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards including executing all RA activities 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 regulation

Review and approve promotional materials (e.g., collateral) from cross-functional teams

Manage local Establishment Regulatory Authorization, when applicable

Partner with CoE team in the Review of local generated promotional materials to comply with local regulatory requirements when needed

Interaction with QA for FCA & vigilance reports, Facilitate Q&As with local CAs for FCA, adverse events & vigilance reports

Assist with special projects on as -needed basis
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

This is a temporary position with possibilities of becoming fixed in the long term
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 Specialist

    6 meses 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...

  • Regulatory Affairs Specialist for Pharmaceutical Products

    2 semanas atrás

    São Paulo, São Paulo, Brasil Sully's Steamers Johnson City Tempo inteiro

    Sully's Steamers Johnson City seeks a highly skilled Regulatory Affairs Specialist to coordinate, compile and submit new drug/medical devices applications to regulatory agencies in Brazil.The ideal candidate will plan, conduct and coordinate JJV regulatory activities for Brazil, working closely with RA management to establish and execute regulatory...

  • Ra Manager

    Há 1 mês

    São Paulo, São Paulo, Brasil MSN Laboratories Tempo inteiro

    Regulatory Affairs Role at MSN LaboratoriesWe are seeking a skilled Regulatory Affairs professional to join our team at MSN Laboratories. The successful candidate will be responsible for ensuring compliance with regulatory requirements across various countries.Key Responsibilities:Review and analyze new regulatory records for submission to relevant...

  • Regulatory Affairs Analyst

    6 meses atrás

    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

    6 meses 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 Specialist

    4 semanas atrás

    São Paulo, Brasil Abbvie Tempo inteiro

    The Specialist, Regulatory Affairs Area, develops and executes regulatory strategies in alignment with Global and Affiliate Regulatory colleagues as appropriate. S / he represents Area on the Global Regulatory Product Teams (GRPTs) and leads Area Regulatory Product Teams (ARPTs) to identify and compile the information necessary to register and properly...

  • Regulatory Affairs Specialist

    4 semanas atrás

    São Paulo, Brasil AbbVie Tempo inteiro

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...

  • Regulatory Affairs Manager

    6 meses 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 Manager

    6 meses atrás

    São Paulo, Brasil JM Huber Corporation Tempo inteiro

    Summary The Regulatory Affairs Manager supports the Regulatory Management System (RMS) for the Specialty Agriculture Solutions (HAS) business unit and Huber Engineered Materials (HEM) internal and external customer systems. The RA Manager provides expertise for regulatory affairs projects supporting business maintenance and / or growth and right to...

  • Regulatory Affairs Specialist

    4 semanas atrás

    São Paulo, Brasil AbbVie Inc Tempo inteiro

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products...

  • Regulatory Affairs Specialist

    Há 1 mês

    São Paulo, Brasil Allergan Tempo inteiro

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...

  • Regulatory Affairs Specialist

    3 semanas atrás

    São Paulo, SP, Brasil Thermo Fisher Scientific Tempo inteiro

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client...

  • Regulatory Affairs Specialist for Medication and Medical Devices in Brazil

    2 semanas atrás

    São Paulo, São Paulo, Brasil Sully's Steamers Johnson City Tempo inteiro

    **Job Title:** Regulatory Affairs Specialist for Medication and Medical Devices in Brazil About the Role:Sully's Steamers Johnson City is seeking a highly skilled Regulatory Affairs Specialist to join our team in Brazil. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with local regulations and...

  • Regulatory Affairs Specialist

    6 meses 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...

  • Vaga de Regulatory Affairs Team Manager

    Há 1 mês

    São Paulo, Brasil Catho Online Ltda. - BR - Chefe Tempo inteiro

    Job title: Regulatory Affairs Team Manager - Vaga Exclusiva Para Pessoas com Deficiencia (PcD) Location: São Paulo/SP About the jobRegulatory Affairs team in Brazil is part of a single digitally savvy and agile regulatory community effectively partnering with our diverse business units and platforms by building constructive relationships with Health...

  • Regulatory Affairs Manager

    4 meses atrás

    São Paulo, Brasil MSN Laboratories Tempo inteiro

    Survey and implementation of processes, policies and procedures that guarantee compliance and continuity of Regulatory Affairs in each country.Responsible for the review, analysis and filing of new records before the regulatory entity in each country.Responsible for renewals and monitoring of health records.Responsible for responding to the requests or...

  • Regulatory Affairs Manager

    4 meses atrás

    São Paulo, Brasil MSN Laboratories Tempo inteiro

    Survey and implementation of processes, policies and procedures that guarantee compliance and continuity of Regulatory Affairs in each country.Responsible for the review, analysis and filing of new records before the regulatory entity in each country.Responsible for renewals and monitoring of health records.Responsible for responding to the requests or...

  • Regulatory Affairs Manager

    4 meses atrás

    São Paulo, SP, Brasil MSN Laboratories Tempo inteiro

    Survey and implementation of processes, policies and procedures that guarantee compliance and continuity of Regulatory Affairs in each country. Responsible for the review, analysis and filing of new records before the regulatory entity in each country. Responsible for renewals and monitoring of health records. Responsible for responding to the requests...

  • Regulatory Affairs Specialist – LATAM – Johnson

    Há 1 mês

    São Paulo, Brasil Johnson & Johnson Tempo inteiro

    Titulo da Vaga: Regulatory Affairs Specialist – LATAM Nome da Empresa: Johnson & Johnson Localização: São Paulo – SP Descrição da Vaga: 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. Through our expertise in...

  • Vaga De Regulatory Affairs Team Manager

    Há 1 mês

    São Paulo, Brasil Catho Online Ltda. - BR - Chefe Tempo inteiro

    Job title:Regulatory Affairs Team Manager - Vaga Exclusiva Para Pessoas com Deficiencia (PcD)Location:São Paulo/SPAbout the jobRegulatory Affairs team in Brazil is part of a single digitally savvy and agile regulatory community effectively partnering with our diverse business units and platforms by building constructive relationships with Health Authorities...