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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 Jr. Regulatory Affairs Analyst is an entry-level position that supports the Brazil Regulatory Affairs group to prepare submission and registration documents in support of new or existing product offerings. The candidate is required to 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.
  • Under supervision, provide administrative support to the Brazil Regulatory Affairs group, with activities that include 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 - written and verbal skills.
  • Bachelor's degree in a science or engineering field.
  • Minimum of 2 years experience within the Medical Device industry.
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.
  • Proficient in MS Word, Excel, PowerPoint, and Outlook.
  • Good understanding of domestic and international medical device regulations.
Travel Requirements
  • Up to 10%.

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status.