Empregos atuais relacionados a Regulatory Affairs Specialist - São Paulo, São Paulo - Teleflex

  • Regulatory Affairs Specialist

    4 semanas atrás

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

    **Regulatory Affairs Role Summary**At Sully's Steamers Johnson City, we are seeking a highly skilled Regulatory Affairs Specialist to coordinate, compile, and submit new drug/medical devices applications to regulatory agencies.**Key Responsibilities**Plan, conduct, and coordinate JJV regulatory activities for Brazil.In partnership with RA management,...

  • Regulatory Affairs Specialist

    Há 1 mês

    São Paulo, São Paulo, Brasil Intrials Clinical Research Tempo inteiro

    Job Title: Regulatory Affairs SpecialistAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Intrials Clinical Research. As a Regulatory Affairs Specialist, you will be responsible for managing regulatory and start-up activities for clinical trials in Latin America.Key Responsibilities:- Manage regulatory and...

  • Regulatory Affairs Specialist

    4 semanas atrás

    São Paulo, São Paulo, Brasil Baxter Tempo inteiro

    **Transforming Healthcare through Regulatory Excellence**Baxter is a leading medical technology company that has been pioneering significant medical innovations for over 85 years. Our mission is to save and sustain lives, and we're looking for a talented Regulatory Affairs Specialist to join our team.As a Regulatory Affairs Specialist at Baxter, you will be...

  • Regulatory Affairs Specialist

    4 semanas atrás

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

    Kenvue is seeking a highly skilled Regulatory Affairs Specialist to join our team. This role reports into Manager, Global Reg Strategic Compliance and is based at Brazil. São Paulo Capital.As a Regulatory Affairs Specialist, you will be responsible for developing and maintaining PowerBI Dashboards and reports for Regulatory systems and databases. You will...

  • Regulatory Affairs Specialist

    4 semanas atrás

    São Paulo, São Paulo, Brasil Teleflex Tempo inteiro

    About TeleflexTeleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine,...

  • Regulatory Affairs Specialist

    Há 1 mês

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

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Thermo Fisher Scientific. As a key member of our regulatory team, you will be responsible for ensuring compliance with local regulatory requirements and providing strategic advice to internal clients.Key ResponsibilitiesPrepare and review local regulatory...

  • Regulatory Affairs Specialist

    4 semanas atrás

    São Paulo, São Paulo, Brasil Gilead Sciences Tempo inteiro

    Job Title: Regulatory Affairs ManagerGilead Sciences is seeking a highly skilled Regulatory Affairs Manager to join our team in Sao Paulo. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to maximize regulatory success.Key Responsibilities:Support the...

  • Regulatory Affairs Specialist

    4 semanas atrás

    São Paulo, São Paulo, Brasil Teleflex Tempo inteiro

    About Teleflex IncorporatedTeleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology,...

  • Regulatory Affairs Specialist

    4 semanas atrás

    São Paulo, São Paulo, Brasil Pfizer Tempo inteiro

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pfizer. The successful candidate will be responsible for performing activities related to initial dossier submissions and registration maintenance of company products, legal documents, and/or systems.Key ResponsibilitiesParticipate in meetings with Anvisa, other...

  • Regulatory Affairs Specialist

    Há 1 mês

    São Paulo, São Paulo, Brasil Parexel Tempo inteiro

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Parexel. As a Senior Regulatory Associate, you will play a key role in supporting Regulatory Authority Submissions related to Clinical Trials in Brazil.Key ResponsibilitiesPrepare and submit RA Applications ensuring deadlines are met.Conduct quality control of...

  • Regulatory Affairs Specialist

    4 semanas atrás

    São Paulo, São Paulo, Brasil Edwards Lifesciences Tempo inteiro

    Make a meaningful difference to patients around the world by joining Edwards Lifesciences as a Regulatory Affairs Specialist. Our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments.Key ResponsibilitiesCompletes and maintains regulatory approvals and clearances of assigned products.Creates...

  • Regulatory Affairs Specialist

    4 semanas atrás

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

    Job SummaryThe Regulatory Affairs Senior Analyst will play a key role in ensuring compliance with regulatory requirements and ensuring the company's products are approved and marketed in a timely manner. This position requires a strong understanding of regulatory processes and procedures, as well as excellent communication and analytical skills.Key...

  • Regulatory Affairs Specialist for Pharmaceutical Products

    Há 2 dias

    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...

  • Regulatory Affairs Manager

    4 semanas atrás

    São Paulo, São Paulo, Brasil MSN Laboratories Tempo inteiro

    Regulatory Affairs Job DescriptionAt MSN Laboratories, we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality of our pharmaceutical products.Key Responsibilities:Develop and implement regulatory...

  • Ra Manager

    3 semanas atrás

    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...

  • Medical Device Regulatory Affairs Specialist

    3 semanas atrás

    São Paulo, São Paulo, Brasil Teleflex Tempo inteiro

    About Teleflex in BrazilTeleflex Incorporated is a leading global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with...

  • Regulatory Affairs Manager

    Há 1 mês

    São Paulo, São Paulo, Brasil MSN Laboratories Tempo inteiro

    Key Responsibilities: Survey and implement processes, policies, and procedures to ensure Regulatory Affairs compliance and continuity in each country. Review, analyze, and file new records with regulatory entities in each country. Oversee renewals and monitoring of health records. Respond to requests or requirements from territorial entities or legal...

  • Regulatory Affairs Specialist

    4 semanas atrás

    São Paulo, São Paulo, Brasil Gilead Sciences Farmaceutica do Brasil Ltda Tempo inteiro

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences Farmaceutica do Brasil Ltda. This is an exciting opportunity for an experienced regulatory professional to contribute to the development and execution of robust regulatory strategies while ensuring regulatory compliance.Key ResponsibilitiesSupport the...

  • Regulatory Affairs Specialist for Medication and Medical Devices in Brazil

    Há 3 dias

    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 Senior Specialist

    Há 1 mês

    São Paulo, São Paulo, Brasil Novo Nordisk Tempo inteiro

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Senior Specialist to join our team at Novo Nordisk. As a key member of our Regulatory Affairs department, you will be responsible for spearheading the development and expertise in synthetic molecules category, contributing to internal and HQ discussions for implementing synthetic products in...

Regulatory Affairs Specialist

4 semanas atrás

São Paulo, São Paulo, Brasil Teleflex Tempo inteiro
About Teleflex

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine, and respiratory care.

Job Summary

The Pl. Regulatory Affairs Analyst is a developing-level position that supports the Brazil Regulatory Affairs group to prepare submission and registration documents supporting new or existing product offerings. The candidate must work effectively with cross-functional groups and global regulatory affairs contacts to maintain Brazil clearances/approvals.

Key Responsibilities
  • Understand regulatory processes, guidelines, and guidance documents and what they mean to the organization.
  • Communicate with internal stakeholders.
  • Interface with various departments to collect and organize required documentation materials.
  • Data entry, remediation, and maintenance of various regulatory databases.
  • Assist in compiling new or revised medical device submissions and dossiers for import permits.
  • Begin education on relevant domestic and Latin American regulatory requirements for medical devices.
  • Support the Regulatory Impact Assessment process.
  • Discuss about GAP Assessments regarding regulatory updates.
  • Provide administrative support to the Brazil Regulatory Affairs group, including securing certified copies, processing payment requests, and coordinating dossier deliveries to third parties.
  • Perform regulatory due diligence process.
  • Manage INMETRO certificates.
  • Lead local projects with orientation.
Requirements
  • English proficiency is a Must - written and verbal skills.
  • Bachelor's degree in a science or engineering field.
  • Minimum of 5 years experience with Class I or II medical devices.
  • Experience with Class III or IV medical devices (preferable).
  • Experience in INMETRO certification (preferable).
Preferred Skills
  • Strong communication skills (verbal and technical writing).
  • Orientation to teamwork, problem-solving ability, customer focus, and a commitment to quality.
  • Strong organization skills, multi-tasking, meeting deadlines, and being detail-oriented.
  • Knowledge of electronic document management systems.
  • Ability to apply Business and Regulatory Affairs ethical standards; analytical and critical thinking skills.
  • Hability to manage the tasks and meet the deadlines.
  • Proficient in MS Word, Excel, PowerPoint, and Outlook.
  • Preferred: understanding of domestic and international medical device regulations.
Travel Requirements
  • Up to 10%.