Global Regulatory Compliance Student / internship (BB-A0F4B)

Encontrado en: Neuvoo CR

Global Regulatory Compliance Intern is a position for actively College students who will support the Global Regulatory Compliance Department. This position effectively supports the complaint handling process and processes complaints in a uniform and timely manner. This position will act as the “single point” of contact between internal and external customers, Sales organization, HCPs, nurses and patients, concerning products issues, product information, patient requests and complaints. The person receives first information from markets upon complaint information, evaluates incoming data and enters available data into the Global Complaint Handling Database. Communicates with customers and requests necessary complaint information from Complainant and involved parties. Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information. Communicates results of complaint investigation back to customers and is responsible to review the complaint for completeness and accuracy before closure of the complaint. The person will be trained before any activity is performed and will be supervised by the Global Regulatory Compliance Trainer during the training activities. The person is determining the need for regulatory reporting (Medical Device Reporting, Vigilance Reporting) of Complaints to Regulatory Bodies in US and OUS. Runs the decision tree for reportability to NCAs and documents decisions on reportability in the system. The reports will not be performed by the Global Regulatory Compliance Intern. Works with local in country RA/QA representatives on determination and filing of foreign incident reports. Prepares responses to standard requests from Regulatory Bodies. Under the direction of the Regulatory Compliance Manager, this position manages activities and procedures associated with complaint communication. It is accountable for setting own work direction and completing work tasks. ESSENTIAL FUNCTIONS Position Functions % of Position -Receives, reviews and enters product complaint information into the complaint handling database. -Interact with HCPs, Patients and the Sales organization regarding their Product Quality concerns. 50% - Evaluate complaints to determine whether an adverse event report/Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting (93/42/EEC) and any other worldwide regulatory requirements. - Runs decision trees for reportability in the system and documents review - Documents rationale if incident reports are not required. - Works with local RA/QA representatives on determination and filing of foreign incident reports. - Document and maintain records of all adverse events reporting's in accordance with international laws - Complete all required customer complaint/adverse event related documentation in an accurate, professional and timely manner. 30% -Specific requirements related to their field of study. This percentage is based on the College requirements. 20% REQUIREMENTS Travel NA Education Carrer in process: -Nursing -Biology or Microbiology -Eletromedicine Engineering (Biomedicine Engineering) -Engineering: Industrial, Mechanical, etc. -Other related discipline. Licenses/Certifications N/A Experience Active student in College. At least 50% of studies approved. Competencies Strong critical thinking, communication, and problem solving skills Detail Oriented Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors Must have ability to work in a team environment and be self-motivated and organized. Must possess excellent verbal and written communication skills. Must be fluent in English language, verbal and written. Ability to work independently. Ability to work in an international environment. Strong feeling for Accountability. Must have very good understanding of Microsoft Office applications Other Ability to work with a diverse network of both internal and external groups and/or individuals. Strong interpersonal and communication skills, both written and verbal. Must be motivated and able to manage multiple projects with key deadlines. Physical Demands (Insert only those applicable to position): Weight Lifting: Light (0kg - 5kg) Position: Mostly sitting Repetitive Motion: Mostly computer use Chemical Exposure: No chemicals exposure. Physical Risk (Personal Protective Equipment – PPE): Occasional use of PPE required, if visiting manufacturing floor

calendar_todayhace 2 días


info Full time

location_on San José, Costa Rica

work Smith+Nephew

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