Pl. Regulatory Analyst

• Understand regulatory processes, guidelines, and guidance documents and what they mean to the

• 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

• 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

• Perform regulatory due diligence process
• Manage INMETRO certificates
• Lead local projects with orientation.
• Comply with Teleflex's Code of Ethics, including all company policies, rules, procedures, and

• Bachelor's degree in a science or engineering field.
• 5 years' experience with Class I or II medical devices
• Experience in INMETRO certification (preferable)
• Experience with Class III or IV medical devices (preferable)
• Languages - English required

• 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

• 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

Teleflex