Regulatory Affairs Specialist

Há 2 horas

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

Teleflex is a global leader in the development and manufacture of medical technologies that improve patient outcomes and enhance the quality of life. Our portfolio includes a diverse range of products and solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, urology, emergency medicine, and respiratory care.

Job Summary

The Jr. Regulatory Affairs Analyst will support the Brazil Regulatory Affairs group in preparing submission and registration documents for new or existing product offerings. This role will require effective communication with cross-functional teams and global regulatory affairs contacts to maintain Brazil clearances and approvals.

Key Responsibilities
  1. Understand and apply regulatory processes, guidelines, and guidance documents to ensure compliance with domestic and international regulations.
  2. Communicate effectively with internal stakeholders to collect and organize required documentation materials.
  3. Interface with various departments to ensure timely and accurate submission of regulatory documents.
  4. Assist in compiling new or revised medical device submissions and dossiers for import permits.
  5. Develop knowledge of relevant domestic and Latin American regulatory requirements for medical devices.
  6. Provide administrative support to the Brazil Regulatory Affairs group, including securing certified copies, processing payment requests, and coordinating dossier deliveries to third parties.
  7. Assist in the regulatory due diligence process.
Requirements
  • English proficiency is a must, with strong written and verbal communication skills.
  • Bachelor's degree in a science or engineering field.
  • Minimum of 2 years of experience within the Medical Device industry.
Preferred Skills
  • Strong communication and organizational skills.
  • Ability to apply business and regulatory affairs ethical standards.
  • Knowledge of electronic document management systems.
  • Proficient in MS Word, Excel, PowerPoint, and Outlook.
Travel Requirements

Up to 10% travel required.

Teleflex is an affirmative action and equal opportunity employer. We welcome applications from diverse candidates and are committed to creating an inclusive work environment.

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