Regulatory Affairs Specialist
3 semanas atrás
Teleflex is a leading global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. Our purpose-driven innovation focuses on identifying unmet clinical needs to benefit patients and healthcare providers. Our diverse portfolio encompasses solutions in vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine, and respiratory care.
Position OverviewThe 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. This role requires effective collaboration with cross-functional groups and global regulatory affairs contacts to maintain Brazil clearances/approvals.
Key Responsibilities- Stay up-to-date with regulatory processes, guidelines, and guidance documents and their implications for the organization.
- Communicate effectively with internal stakeholders.
- Interface with various departments to collect and organize required documentation materials.
- Perform data entry, remediation, and maintenance of 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.
- 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.
- Up to 10%
Teleflex 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.
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