Regulatory Affairs Specialist

Há 5 horas

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

Teleflex is a global leader in the development and manufacture of clinically effective medical technologies. Our purpose-driven innovation is focused on identifying unmet clinical needs and delivering solutions that improve the health and quality of people's lives. With a diverse portfolio of products, we serve a wide range of healthcare providers and patients worldwide.

Position Summary

The Regulatory Affairs Analyst will play a key role in supporting the Brazil Regulatory Affairs team in preparing submission and registration documents for new or existing product offerings. This role will require effective communication with cross-functional groups and global regulatory affairs contacts to maintain Brazil clearances and approvals.

Key Responsibilities
  • Develop and maintain knowledge of regulatory processes, guidelines, and guidance documents.
  • Collaborate with internal stakeholders to ensure compliance with regulatory requirements.
  • Interface with various departments to collect and organize required documentation materials.
  • Manage regulatory databases and perform data entry, remediation, and maintenance tasks.
  • Assist in compiling new or revised medical device submissions and dossiers for import permits.
  • Support the Regulatory Impact Assessment process and discuss GAP Assessments regarding regulatory updates.
  • Provide administrative support to the Brazil Regulatory Affairs group, including securing certified copies and coordinating dossier deliveries.
  • Perform regulatory due diligence and manage INMETRO certificates.
Requirements
  • English proficiency is a must, with strong written and verbal skills.
  • Bachelor's degree in a science or engineering field.
  • Minimum of 5 years of experience with Class I or II medical devices.
  • Experience with Class III or IV medical devices is preferred.
  • Experience in INMETRO certification is preferred.
Preferred Skills
  • Strong communication and technical writing skills.
  • 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.
  • Proficient in MS Word, Excel, PowerPoint, and Outlook.
Travel Requirements
  • Up to 10% travel required.

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