Regulatory Affairs Specialist
3 semanas atrás
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
4 semanas atrás
Paulo, Brasil Mindray Tempo inteiroBe part of Mindray Brazil as Regulatory Affairs Specialist!!Mindray is a Chinese multinational manufacturer of medical instruments with headquartered
-
Regulatory Affairs Specialist
3 semanas atrás
São Paulo, Brasil Mindray Tempo inteiroBe part of Mindray Brazil as Regulatory Affairs Specialist!!Mindray is a Chinese multinational manufacturer of medical instruments with headquartered in Shenzhen, Guangdong. The company designs and produces medical equipment and accessories, with presence in more than 190 countries and regions, with a strong commitment with research and development. Our...
-
Regulatory Affairs Specialist
4 semanas atrás
São Paulo, SP, Brasil Mindray Tempo inteiroBe part of Mindray Brazil as Regulatory Affairs Specialist!! Mindray is a Chinese multinational manufacturer of medical instruments with headquartered in Shenzhen, Guangdong. The company designs and produces medical equipment and accessories, with presence in more than 190 countries and regions, with a strong commitment with research and development. Our...
-
Regulatory Affairs Specialist
4 semanas atrás
São Paulo, SP, Brasil Mindray Tempo inteiroBe part of Mindray Brazil as Regulatory Affairs Specialist!! Mindray is a Chinese multinational manufacturer of medical instruments with headquartered in Shenzhen, Guangdong. The company designs and produces medical equipment and accessories, with presence in more than 190 countries and regions, with a strong commitment with research and development. Our...
-
Regulatory Affairs Specialist
4 semanas atrás
são paulo, Brasil Mindray Tempo inteiroBe part of Mindray Brazil as Regulatory Affairs Specialist!! Mindray is a Chinese multinational manufacturer of medical instruments with headquartered in Shenzhen, Guangdong. The company designs and produces medical equipment and accessories, with presence in more than 190 countries and regions, with a strong commitment with research and development. Our...
-
Regulatory Affairs Specialist
4 semanas atrás
Greater São Paulo Area, BR Mindray Tempo inteiroBe part of Mindray Brazil as Regulatory Affairs Specialist!!Mindray is a Chinese multinational manufacturer of medical instruments with headquartered in Shenzhen, Guangdong. The company designs and produces medical equipment and accessories, with presence in more than 190 countries and regions, with a strong commitment with research and development. Our...
-
Regulatory Affairs Specialist
4 semanas atrás
Greater São Paulo Area, Brasil Mindray Tempo inteiroBe part of Mindray Brazil as Regulatory Affairs Specialist!!Mindray is a Chinese multinational manufacturer of medical instruments with headquartered in Shenzhen, Guangdong. The company designs and produces medical equipment and accessories, with presence in more than 190 countries and regions, with a strong commitment with research and development. Our...
-
Regulatory Affairs Specialist
4 semanas atrás
Greater São Paulo Area, Brasil Mindray Tempo inteiroBe part of Mindray Brazil as Regulatory Affairs Specialist!! Mindray is a Chinese multinational manufacturer of medical instruments with headquartered in Shenzhen, Guangdong. The company designs and produces medical equipment and accessories, with presence in more than 190 countries and regions, with a strong commitment with research and development. Our...
-
Regulatory Affairs Specialist
4 semanas atrás
Sao Paulo Metropolitan Area, Brasil Mindray Tempo inteiroBe part of Mindray Brazil as Regulatory Affairs Specialist!!Mindray is a Chinese multinational manufacturer of medical instruments with headquartered in Shenzhen, Guangdong. The company designs and produces medical equipment and accessories, with presence in more than 190 countries and regions, with a strong commitment with research and development. Our...
-
Regulatory Affairs Specialist
3 semanas atrás
São Paulo, Brasil Edwards Lifesciences Tempo inteiroMake 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
Há 3 dias
Sao Paulo, Brasil Edwards Lifesciences Tempo inteiroMake 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 3 dias
Sao Paulo, Brasil Edwards Lifesciences Tempo inteiroMake 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 Manager
Há 4 dias
São Paulo, São Paulo, Brasil Abbott Laboratories Tempo inteiroAbout 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 Specialist
3 semanas atrás
São Paulo, Brasil Fortrea Tempo inteiroJob Overview: Responsible for creation/revision and compilation of stability data and annual product quality review documents for submission by Fortrea clients to LATAM and oversight of the same. Should be proficient in English, Portuguese, Spanish languages. Knowledge of LATAM quality regulations. Summary of Responsibilities: These statements...
-
Regulatory Affairs Specialist
3 semanas atrás
São Paulo, Brasil Fortrea Tempo inteiroJob Overview: Responsible for creation/revision and compilation of stability data and annual product quality review documents for submission by Fortrea clients to LATAM and oversight of the same. Should be proficient in English, Portuguese, Spanish languages. Knowledge of LATAM quality regulations. Summary of Responsibilities: These statements are...
-
Regulatory Specialist Latam
3 semanas atrás
São Paulo, Brasil Red Bull Tempo inteiroThe legal team protects Red Bull, its people, partners and vendors by adding value to each product line and initiative. Legal is divided into Legal Business Partners for the Beverage Business and Corporate Projects, Specialist Departments and Centers of Expertise. The Regulatory Specialist assists the LATAM Regional team by offering technical and legal...
-
Regulatory Affairs Sr. Analyst
Há 7 dias
São Paulo, Brasil Novo Nordisk AS Tempo inteiroAre you passionate about ensuring regulatory compliance for pharmaceutical products? Do you have experience in regulatory affairs and a strong understanding of the submission process? We are looking for a Regulatory Affairs Sr. Analyst to join our team at Novo Nordisk. If you are ready for a new challenge and want to make a difference in the...
-
Associate Director Regulatory Affairs
4 semanas atrás
Sao Paulo, Brasil Johnson & Johnson Tempo inteiroAt Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives. In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional...
-
Regulatory Affairs Specialist LATAM
Há 7 horas
São Paulo, Brasil Vantage Specialty Chemicals Tempo inteiroVantage is a leading supplier of naturally derived specialty ingredients and formulations that cater to the evolving needs of industrial and consumer markets. Through our chemistries, our customer focus and our global footprint, we are ENABLING TOMORROW’S SOLUTIONS TODAY.As a company on the move, you’ll be working as part of a collaborative team and...
-
Regulatory Affairs Manager
2 semanas atrás
São Paulo, Brasil Abbott Tempo inteiroThe Opportunity This position works out of our São Paulo location in the Diagnostic Division. As a RA Manager you’ll have to ensure that all imported/marketed products by Core Diagnostic, Molecular and Point of Care Divisions are registered with the Regulatory Authority in compliance with the current sanitary regulations. What You’ll Do 1....