Regulatory Affairs Specialist
4 semanas atrás
About Teleflex Incorporated
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 various fields, including vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine, and respiratory care.
Latin America Region
The Latin America Region of Teleflex is headquartered in Morrisville, North Carolina, and supports our customers, distributors, sales managers, and specialists in Mexico, Brazil, Colombia, Chile, Argentina, and Puerto Rico. We sell a broad spectrum of medical devices and related products in various fields.
Position Summary
The Regulatory Affairs Analyst is a developing-level position that supports the Brazil Regulatory Affairs group to prepare submission and registration documents for new or existing product offerings. The candidate must 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 their impact on the organization.
- Communicate with internal stakeholders and interface with various departments to collect and organize required documentation materials.
- 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, processing payment requests, and coordinating dossier deliveries to third parties.
- Manage INMETRO certificates and perform regulatory due diligence processes.
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 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.
Travel Requirements
- Up to 10% travel is required.
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