Vigliance Specialist 80 - 100 %

Vigliance Specialist% (w/m/d)True to the vision "We drive innovation to improve people's lives", the Hamilton companies have been providing solutions for the health sector sinceWe are an innovative pioneer in the field of ventilators.Hamilton Medical is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport or an MRI scan - our solutions cover a multitude of patient groups, applications and environments.How you can make a difference:Reportability AssessmentCreation of initials reports in a timely mannerOwnership on deadline to conduct tasks as per given timeframe from the applicable requirementsCreating final reports based on investigationSense of communication with diverse stakeholders internally or externallyCommunication with health competent authorities with a certain complexity levelPrepare overviews of reported events for notified body or competent authoritiesPrepare statistics for yearly management reviewParticipate at audits and inspectionsProvide support on processes' improvementsSupport team members on daily tasks acting as a coachThat's what you bring along:Strong experience in Post-Market Surveillance, with focus on Vigilance (Reporting tasks), i.e., analyzing need for reportability, creating initials, follow up in a timely manner and create final reports based on the provided investigationCapability to communicate with health competent authoritiesBeing able to challenge the quality of data provided and ensure data integrityKnowledge with quality systems such as complaint handling and CAPASolid Knowledge on medical devices regulations (EU-MDR, FDA 21CFR 803 and MDSAP countries)Fluent in English and GermanGood communication and problem-solving skillsStructured methodology for good documentation practicesWilling to be curious and to learnAbility to set up priorities and acting in a timely mannerHow to apply:Learn more about career opportunities at Hamilton at Jobs | Hamilton Medical.Do you share our values and feel at home in a cooperative, innovative,and down-to-earth environment? At Hamilton, we not only offer a motivating working environment, but also purposeful workand modern working conditions. Our interactions at eye level encourage open communication and a pleasant working environment. Become part of a team where your skills are valued and innovative ideas are fostered. Interested? Then apply online using the "Apply now" button. If you have any questions, please contact us at E-Mail schreiben with the following details:Reference: JRfjm/Contact: Juli ThomannApplications by post or e-mail can unfortunately not be considered. jid0e2d672pn jit0209pn jiy26pn