Supervisor, global regulatory compliance


¢ 1,5 a 2 millones CRC

Toda Costa Rica

Publicado 10 Oct 2018


2 Vacantes

Administración de Empresas / Otras

Sector de la vacante:
Industrias manufactureras

Descripción general

Lead and support a team of Regulatory Compliance Analysts for the following tasks related to Complaint Intake, Follow-Up and Closure Communication: -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. - Continuously monitors the information gathering process and tracks the status of complaint communication until end customer communication. 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 - Ensures that incident reports to U.S., European and International NCAs are submitted within the regulatory timeframes. Documents rationale if incident reports are not required.  - Prepares, generates and submits incident reports (MDR,MDV, etc.) upon adverse events and submits follow-up and final reports to U.S. - Prepares and monitores daily or weekly team productivity reports - Runs ad hoc reports as requested. Prepares data for reports as requested.  - Prepares monthly/quarterly reports.  - Identify and Investigate solutions to procedure and process related issues.

Requisitos para aplicar

Bachelor degree in biology, health sciences, engineering, nursing, law or other related discipline.  -3-5 years Medical Device Reporting/OUS Adverse Event Reporting experience in medical devices-Regulatory knowledge with complaint handling; adverse event reports; recalls and quality systems. - Must possess excellent verbal and written communication skills. - Must be fluent in English language, verbal and written. - Additional language such as German, French, Italian, Chinese or Japananese beneficial -Ability to work independently. - Ability to work in an international environment. -  Must be motivated and able to manage multiple projects with key deadlines

Datos complementarios




Bachillerato edu. diversificada

Equipo medico

6 años de experiencia


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