Regulatory Affairs Specialist
4 semanas atrás
Be 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 mission is focus on Advance medical technologies to make healthcare more accessible.
With Mindray as Regulatory Affairs Specialist, your main responsabilities will be:
Support manager in daily activities related to Regulatory Compliance such as:
- Maintaining the company's legal documentation – contracts governaments reports
- Follow up expire registration in estances like ANVISA, INMETRO and other regulatory bodies, so that the products can be sold in the national territory.
Main activities
- Assessment of current technical documentation and its updates for preparing dossies for:registration, post-registration and registration renewal and submite in relater webiste and follow up the process;
- Follow up update laws and requisitions which can impact in current or future product registration;
- Meeting all the specific requirements of each product line, if any, to understand the strategy to register product;
- Support in regulatory routine activities: database updating, translations, manuals updates, local payments in Concur and area reports;
- Assessment of applicable legislation published by health bodies, interpretation and reporting to management in China with preparation of an adaptation plan, when necessary
- Support for questioning internal (tenders/imports) and external customers regarding the applicability of local legislation
- Interface with Quality department providing documents/informations for external audits;
- Effective participation in meetings promoted by health supervisory bodies and professional associations (ABIMED, CBDL, ABIMO, etc.)
Requirements
- Degree in Biomedical or Farmacy
- Excel
- Advanced English
- Local laws – RDC , Anvisa procedures
- Previous experience in medical devices companies – or pharmaceutical
- At least 5 years of experience working as Regulatory Affairs Analyst/ Specialist or similar roles.
Mindray Brazil offers an exciting professional environment. Only those who meet our requirements will be contacted. Mindray is an equal opportunity employer.
-
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
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
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
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
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 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 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
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....