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Regulatory Affairs Specialist

2 meses atrás

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

Teleflex is a global leader in the development and manufacturing of medical technologies designed to improve patient outcomes and quality of life. Our portfolio encompasses a diverse range of products and 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 Jr. Regulatory Affairs Analyst is an entry-level position that supports the Brazil Regulatory Affairs group in preparing submission and registration documents for new or existing product offerings. The successful candidate will work effectively with cross-functional teams and global regulatory affairs contacts to maintain Brazil clearances and approvals.

Key Responsibilities
  • Understand and apply regulatory processes, guidelines, and guidance documents to ensure compliance with organizational requirements.
  • Communicate effectively with internal stakeholders to collect and organize required documentation materials.
  • Interface with various departments to collect and organize required documentation materials.
  • Enter, remediate, and maintain 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.
  • Provide administrative support to the Brazil Regulatory Affairs group, including securing certified copies, processing payment requests, and coordinating dossier deliveries to third parties.
  • Assist in the regulatory due diligence process.
Requirements
  • English proficiency is a must, with strong written and verbal skills.
  • Bachelor's degree in a science or engineering field.
  • Minimum of 2 years of experience within the Medical Device industry.
  • Strong communication skills, including 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.
  • Proficient in MS Word, Excel, PowerPoint, and Outlook.
  • Good understanding of domestic and international medical device regulations.
Travel Requirements

Up to 10% travel may be required.